MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 21MM, STRAIGHT; STAPLE, IMPLANTABLE

Model Number	SDH21A
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2020
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.Photo received and pending evaluation.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.
Event or Problem Description
It was reported that during the total gastrectomy, after fired with audible feedback, removed the device, the donut were complete as photo show, but noted 1/2 tissue without staples, checked surgical area, did not find any staples.Used suture to oversew and the surgery delayed one and half an hour.The patient's condition is currently stable.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/14/2020.Per photographic evaluation: upon visual inspection of three photos, the following was observed: the first and second photos show a device from anvil area and the washer appears to be totally cut inside of anvil.Also, the washer appears to be nicks.The third photo shows tissue on the hands of user and one part of tissue appears to be did not stapler.Based on the photos reviewed, the event describe is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.As the device was not returned, an analysis investigation could not be performed.  a conclusion could not be reached as to what may have caused or contributed to the event. .
Additional Manufacturer Narrative
(b)(4).Date sent: 10/15/2020.As the device was not returned, an analysis investigation could not be performed.  a conclusion could not be reached as to what may have caused or contributed to the event. .

• Brand Name: ILS 21MM, STRAIGHT
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10593203
• Report Number: 3005075853-2020-04943
• Device Sequence Number: 19120673
• Product Code: GDW
• UDI-Device Identifier: 10705036003519
• UDI-Public: 10705036003519
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/06/2020

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: 06/30/2022
• Device Model Number: SDH21A
• Device Catalogue Number: SDH21A
• Device Lot Number: P4RT3A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2020
• Supplement Date Received by Manufacturer: 10/13/2020; 10/14/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 10/14/2020; 10/15/2020
• Patient Sequence Number: 1