MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD 23MM CURVED CIRCULAR, 18CM SHAFT; STAPLE, IMPLANTABLE

Catalog Number CDH23P

Device Problem Failure to Cut (2587)

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

Event Date 03/06/2024

Event Type  malfunction  

Event Description

It was reported that during an esophageal surgery, after fired, noted that the tissue was not cut, but there were some staples deployed on the tissue, then changed another device to complete the procedure.There was no patient consequences reported.No additional information could be provided.There were no missing staples from the staple line.

Manufacturer Narrative

(b)(4).Date sent 3/12/2024.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.No lot or batch number was provided therefore a device history could not be done.Photo images were received.Any additional information obtained from the photo evaluation will be included as part of the product investigation.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: 4/8/2024.D4: batch # 623c66.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 cdh23p 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.Additionally, photos were provided and they showed a piece of box and a device of top view.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.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 623c66, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: PWRD 23MM CURVED CIRCULAR, 18CM SHAFT
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; PR ; 3035526892
• MDR Report Key: 18893845
• MDR Text Key: 337571178
• Report Number: 3005075853-2024-02141
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036015369
• UDI-Public: 10705036015369
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDH23P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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