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

Catalog Number	SDH25A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # r58u27.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot and batch.
Event or Problem Description
It was reported: could not fire.During the laparoscopic radical resection of colon cancer, could not squeeze down the firing trigger even with big force, without audible feedback, half of staples were malformed.Suture was used to complete the surgery.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Additional manufacturer narrative/corrected data - updated device evaluation updated device evaluation: initial analysis: the analysis results found that the sdh25a device arrived with no apparent damage.The breakaway washer uncut and indented and there were no staples present.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 were noted to have the proper b-formed shape.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.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.Additional analysis: the primary intent of the analysis was to measure force-to-fire in a lab setting and to determine if malformed staples were noted when fired.This device was received for additional investigation after initial analysis.The device was fired using the force-to-fire with ils reloads on test skins at the high "b" setting.(this is a conservative approach for staple formation.) firings were performed by r&d design engineer.No malformed staples were observed during firing.The washer was cut during the firing stroke.The force-to-fire values were below the specification limit of 146.3 lbs.And within the manufacturing control limits.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Batch #: r58u27.Device evaluation summary: the analysis results found that the sdh25a device arrived with no apparent damage.The breakaway washer uncut and indented and there were no staples present.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 were noted to have the proper b-formed shape.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.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: ILS 25MM, STRAIGHT
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8168850
• Report Number: 3005075853-2018-15127
• Device Sequence Number: 19194255
• Product Code: GDW
• UDI-Device Identifier: 10705036003526
• UDI-Public: 10705036003526
• 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,Followup,Followup
• Report Date (Section B): 11/22/2018

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: 05/04/2023
• Device Catalogue Number: SDH25A
• Device Lot Number: R40J6K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 11/22/2018
• Supplement Date Received by Manufacturer: 12/19/2018; 03/14/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/10/2019; 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1