MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 33MM, STRAIGHT; STAPLE, IMPLANTABLE

Model Number	SDH33A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #r57157.Device analysis: the analysis results found that the sdh33a device arrived with no apparent damage, with three staples inside the pockets, with the breakaway washer uncut and without marks.The device was reloaded with staples and tested with the returned washer for functionality.The device 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.It should be noted that before firing the device, the orange indicator should be fully within the green range of the gap setting scale and the safety should not be released prior to firing.Also, if the firing sequence is not fully completed (the firing handle reaches its stopping point, and the firing trigger is parallel to the instrument handle), staples could be partially deployed without cutting the washer.Batch records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.
Event or Problem Description
It was reported that during the open left hemicolectomy surgery, the cartridge was loose and staples were protruding.Changed to a new one to complete the surgery.There was no patient consequence reported.No additional information can be provided.

• Brand Name: ILS 33MM, STRAIGHT
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 9667147
• Report Number: 3005075853-2020-00753
• Device Sequence Number: 2650394
• Product Code: GDW
• UDI-Device Identifier: 10705036003540
• UDI-Public: 10705036003540
• 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): 12/11/2019

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: 12/31/2022
• Device Model Number: SDH33A
• Device Catalogue Number: SDH33A
• Device Lot Number: R4022L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/04/2020
• Patient Sequence Number: 1