MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD 31MM CURVED CIRCULAR, 18CM SHAFT; STAPLE, IMPLANTABLE

Catalog Number CDH31P

Device Problems Use of Device Problem (1670); Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure to Anastomose (1028)

Event Date 01/16/2024

Event Type  Injury  

Event Description

It was reported that during a sigmoidectomy and after firing the powered circular stapler, they checked the donuts.The proximal ring was incomplete, and the air leak test failed.The surgeon decided to reinforce the anastomosis by stitching and create an ileostomy.They confirmed that the incident did not occur due to a device error.

Manufacturer Narrative

(b)(4).Date sent: 1/29/2024.D4 batch # unk.H6: health effect ¿ clinical code gastrointestinal system (e10).An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.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: please describe the purse string technique? what does the surgeon believe led to the leak issue? 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: 2/1/2024.Additional information received: purse string technique: double stapling technique, using proline 2-0 for suturing the proximal lumen.The surgeon believes that, even though there were multiple factors involved, the main likely cause of the failure was the purse-string technique.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a serious injury, and has been revised to a usa fda not reportable event.

• Brand Name: PWRD 31MM 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: 18597719
• MDR Text Key: 333982082
• Report Number: 3005075853-2024-00808
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036015390
• UDI-Public: 10705036015390
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K163523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDH31P
• Device Lot Number: A9D805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2023
• 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
• Patient Outcome(s): Required Intervention