Medical device manufacturer, Ethicon Endo-Surgery (Johnson &Johnson), has issued a medical device safety alert concerning its PROXIMATE Hemorrhoidal Circular Stapler. The affected devices are identified as the following: -

• Affected Product: A) PROXIMATE HCS Hemorrhoidal Circular Stapler; B) PROXIMATE PPH Hemorrhoidal Circular Stapler
• Product Code: A)PPH01; B) PPH03]
• Product Lot: A) P9461W, P94K20; B) P93K95, P93L1M, P93M3G, P93T35, P93T7F, P93W3M, P93W3N, P93Y58, P94117, P9420Y, P9420Z, P9441H, P9450L, P9463J, P94765, P9487Z, P94901, P94A20, P94A4T, P94D3N, P94F3Z, P94G04, P94H5F, P94J4W, P94J80, P94K2A, R9200Z.

The manufacturer has initiated a voluntary recall (removal) of specific lots of the affected products. The manufacturer has confirmed that some devices contained in the affected lots may have been assembled without a washer.

According to the manufacturer, it may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired.

The manufacturer has not received any reports of adverse events associated with the issue that led to this recall. The recall does not affect any other lots for PROXIMATE Hemorrhoidal Circular Stapler devices other than the lots stated.

The affected customers are required to take the following actions:

• Examine their inventory immediately and quarantine the affected product.
• Follow the affected patients post-operatively in the usual manner with no additional action required.

Product removal is on-going

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 12 Dec 2018