MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 33MM, CURVED; STAPLE, IMPLANTABLE

Catalog Number CDH33A

Device Problem Failure to Cut (2587)

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

Event Date 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4) date sent: 1/30/2024 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.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.

Event Description

It was reported that during an unknown procedure the circular stapler did not work during the procedure, he stapled the tissue without making the cut.Opening and use of another competitor's circular stapler is required.There was no surgical delay.The procedure was successfully completed.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 3/8/2024.D4: batch # 942a04.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 determined that the cdh33a device arrived with the handles partially opened from the indicator area.The breakaway washer uncut and indented and there were 3 staples inside the pockets.The device was reloaded with staples and tested for functionality with a test washer; during the functional test, the knife did not push the washer not allowing to complete the cut and the staples were partially formed.The instrument was disassembled in order to verify the condition of the internal components and no anomalies were noted.No conclusion could be reached on what caused the handles to be partially opened causing the condition of the incomplete firing.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 942a04, and no non-conformances were identified.

• Brand Name: ILS 33MM, CURVED
• 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: 18609656
• MDR Text Key: 335086804
• Report Number: 3005075853-2024-00854
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036003472
• UDI-Public: 10705036003472
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K983536
• 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: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDH33A
• Device Lot Number: 953A56
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2022
• 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