MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CONTOUR CURVED CUTTER STAPLER; STAPLE, IMPLANTABLE

Catalog Number CS40G

Device Problems Defective Component (2292); Failure to Form Staple (2579)

Patient Problem No Code Available (3191)

Event Date 05/27/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What were the indications for surgery? did the patient receive any preoperative chemotherapy or radiation? what provisions did the surgeon take to ensure the tissue was lying evenly within the jaws? was the device difficult to close? was the device closed and repositioned multiple times prior to firing? was the device difficult to fire? was the distal transection completed in one or multiple firings? were the staples visible on the other 3 staple lines? if so, what was their shape? was the procedure converted to laparotomy due to the issues with the contour device? is the stoma temporary or permanent? what is the current status of the patient?.

Event Description

It was reported that during a colorectal resection regarding the ablation of adenocarcinoma of the lower rectum there was defective stapling; no stapling of the distal end.Only one staple line in four lines has worked.3 staples lines missing.Procedure time extended.Difficult procedure which has been needed to change from laparoscopy to laparotomy (fibromatous uterus and voluminous hard and very adherent mass in posterior which can not be dissected under laparoscopy).The defective device has increase the difficulty of the surgery (left terminal stoma put in place).

Manufacturer Narrative

Product complaint # (b)(4).Batch # p58y31.Device evaluation summary: the analysis results showed that the cs40g device was received with no apparent damage and with a reload present.The reload was received void of staples, with the washer completely cut, drivers exposed and the knife recessed below the cartridge deck.The device was tested for functionality with an engineering sample reload and the device fired, forming all staples and cutting as intended.The cut line and the staple line were complete, and the staples meet the staple form release criteria.The event described could not be confirmed as the device performed without any difficulties noted.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: CONTOUR CURVED CUTTER STAPLER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8744944
• MDR Text Key: 149528623
• Report Number: 3005075853-2019-20142
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036012405
• UDI-Public: 10705036012405
• Combination Product (y/n): N
• PMA/PMN Number: K040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2021
• Device Catalogue Number: CS40G
• Device Lot Number: R92012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2019
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 09/02/2019
• Supplement Dates FDA Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR