MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD 29MM CURVED CIRCULAR, 18CM SHAFT; STAPLE, IMPLANTABLE

Catalog Number CDH29P

Device Problems Failure to Cut (2587); Failure to Eject (4010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2024

Event Type  malfunction  

Event Description

It was reported that during a sigmoid resection the device wouldn't cut all the way when clamped on anastomosis.It fired well but after the firing they felt there was a hole in the anastomosis.They believe it was an issue with the way the surgeon had removed it.No patient harm.

Manufacturer Narrative

(b)(4).Date sent: 1/29/2024.D4 batch # unk.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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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: could you please provide more details of device malfunction? did the device staple? if yes, was the staple line complete (fully circular)? was the breakaway washer completely cut? were there two complete tissue donuts? was it a partial cut? if so what was cut partially, washer or tissue? if yes/no, was there any issue with the cut this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 2/16/2024.D4: batch #587c19.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the cdh29p device arrived with no apparent damage.The breakaway washer was present, cut and there were no staples present.No battery was received.When the test battery was installed the green checkmark illuminated, indicating that the device was fired and achieved complete firing stroke.The device was reloaded with staples, a new washer was placed on the device.The device was reset and tested for functionality with a test battery.It fired and formed all the staples as well as completely cut the test media and the breakaway washer without incident.The staple line was complete, and the staples meet the staple form release criteria.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: do not attempt to manipulate the adjusting knob during the firing sequence.Doing so may result in malformed staples, incomplete cut line, bleeding, and leakage from the staple line and/or difficulty removing the device.To withdraw the open device, rotate it 90° in both directions taking care to minimize movement of the distal tip.This ensures the tissue is released.Gently pull out the device while simultaneously rotating.To inspect the donuts, remove the anvil, washer, and donuts from within the circular knife.The event described could not be confirmed as the device performed without any difficulties.A manufacturing record evaluation was performed for the finished device batch number 587c19, and no non-conformances were identified.

• Brand Name: PWRD 29MM CURVED CIRCULAR, 18CM SHAFT
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; PR ; 3035526892
• MDR Report Key: 18597516
• MDR Text Key: 334553249
• Report Number: 3005075853-2024-00807
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036015383
• UDI-Public: 10705036015383
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDH29P
• Device Lot Number: A9DX4U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1