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

Catalog Number	SDH29A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Only event year known: 2019.Batch # p57r9h.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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that during a hemicolectomy, sdh circular stapler did not fire.The surgery was delayed by 15-minutes.Replaced with a new stapler to complete the surgery.There were no patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4).Batch # p57r9h.Device evaluation summary: the analysis results found that the sdh29a device arrived with no apparent damage.The breakaway washer was present and uncut, the device was fully loaded with staples, indicating that the device had not being fired.The device was tested for functionality with the returned washer and 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.The event described could not be confirmed as the device performed without any difficulties noted.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.A manufacturing record evaluation was performed for the finished device batch number, 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
• MDR Report Key: 9371038
• Report Number: 3005075853-2019-23769
• Device Sequence Number: 3461379
• Product Code: GDW
• UDI-Device Identifier: 10705036003533
• UDI-Public: 10705036003533
• Combination Product (Y/N): N
• PMA/510(K) Number: K983536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

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: 07/28/2022
• Device Catalogue Number: SDH29A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/20/2019
• Patient Sequence Number: 1