MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 29MM, STRAIGHT; STAPLE, IMPLANTABLE

Model Number	SDH29A
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, after fired, noted the staples malformed.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.Procedure: proctrectomy.
Additional Manufacturer Narrative
(b)(4).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 lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.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 field as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent: 04/06/2023.D4: batch # u5d948.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 sdh29a device arrived with no apparent damage.The breakaway washer was present, cut and there were no staples present, indicating that the device achieved a full firing stroke.The device was reloaded with staples, a new washer was placed on the device and it was tested for functionality.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: the firing stroke must be completed.Do not partially fire the instrument.Incomplete firing can result in malformed staples, incomplete cut line, bleeding, and leakage from the staple line and/or difficulty removing the device.Ensure that the firing trigger is fully squeezed to ensure proper staple formation and cutting of tissue.If excessive force is required to close the device, this may indicate there is too much tissue or thickened tissue in the device.Attempting to fire the instrument in this condition may result in poor staple line integrity with possible leakage or disruption.In addition, instrument damage or failure may result.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 u5d948, and no non-conformances were identified.

• Brand Name: ILS 29MM, STRAIGHT
• Common Device Name: 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 ; 3035526892
• MDR Report Key: 16576953
• Report Number: 3005075853-2023-01730
• Device Sequence Number: 1635331
• Product Code: GDW
• UDI-Device Identifier: 10705036003533
• UDI-Public: 10705036003533
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K983536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/23/2025
• Device Model Number: SDH29A
• Device Catalogue Number: SDH29A
• Device Lot Number: U5D948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown