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	10/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
Event or Problem Description
It was reported that during the radical resection of ascending colon cancer procedure, the surgeon did not squeeze down the firing trigger one time (not in one continuous stroke), and the staples fell off.All the staples were retrieved from the patient.Changed to another device to complete the surgery.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Batch r58x9a.Investigation summary: the analysis results found that the sdh29a device arrived with no apparent damage.The breakaway washer uncut and indented and there were no staples present.Device returned was confirmed to have an uncut washer.Device batch information was reviewed, and it was confirmed to be manufactured within bounding time period of the field action, however based on review of manufacturing records, it was not confirmed to exhibit behavior associated with the field action.The device was reloaded with staples and tested for functionality with a test washer; 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.The condition of the washer indicates that the device had not been fired through a full firing stroke or possibly that the orange indicator was not fully into the safe green firing range.It should be noted that before firing the device the orange indicator should be fully within the green range of the gap setting scale.In addition, it should be noted that if the firing sequence is not complete (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.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.

• 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: 8612925
• Report Number: 3005075853-2019-19152
• Device Sequence Number: 14026795
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2019

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: 05/13/2023
• Device Catalogue Number: SDH29A
• Device Lot Number: R40J0P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 06/14/2019
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1277-2019
• Patient Sequence Number: 1