MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 25MM, STRAIGHT; STAPLE, IMPLANTABLE

Model Number	SDH25A
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the low anterior resection 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.
Additional Manufacturer Narrative
(b)(4).Batch # unk.Per photographic evaluation: this is an analysis of a photo submitted for evaluation.During the visual analysis, the following was observed: the photo shows a device of an anvil area in the closed position and no malformed staples could be observed.Based on the photo the event described cannot be confirmed.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was discarded an unavailable for return our evaluation is limited.A manufacturing record evaluation was performed for the finished device lot u40h3j, and no non-conformances were identified.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.

• Brand Name: ILS 25MM, STRAIGHT
• Common Device Name: 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 ; * ; 3035526892
• MDR Report Key: 16008133
• Report Number: 3005075853-2022-08773
• Device Sequence Number: 15095654
• Product Code: GDW
• UDI-Device Identifier: 10705036003526
• UDI-Public: 10705036003526
• 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
• Report Date (Section B): 12/19/2022

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: 07/31/2025
• Device Model Number: SDH25A
• Device Catalogue Number: SDH25A
• Device Lot Number: U40H3J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown