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)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # r5ae4g.Device evaluation summary: the analysis results found that the sdh29a device arrived with the anvil missing.The breakaway washer was not present and there were staples present.All of the staples were noted to be protruding and slightly damaged on the safety.The device was reloaded with staples and tested for functionality.During the functional test, a movement on the ferule and a gap between anvil and guide face were noted.However, the staple line was complete and the staples meet the staple form release criteria.It appears that an attempt was made to fire the device with the safety engaged, allowing the staples to partially protrude.It should be noted that to fire the device, draw the red safety back towards the adjusting knob until it seats into the body of the device.If the safety cannot be released, the device is not in the safe firing range.Please reference the instructions for use for additional information.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 an unknown procedure, it was found that the staples were protruded when the package was opened.The device was not used for the patient.Another device was used to complete the case.There were no adverse consequences to the patient.

• 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: 8522364
• Report Number: 3005075853-2019-17585
• Device Sequence Number: 11230424
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/22/2019

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: 09/14/2023
• Device Catalogue Number: SDH29A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/17/2019
• Patient Sequence Number: 1