MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO GIA; STAPLE, IMPLANTABLE

Model Number	030416
Medical Device Problem Codes	Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	04/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, on a laparoscopic segmentectomy, while detaching the pulmonary vein and lung parenchyma, there was bleeding as the staple line was incomplete proximally.Another reload was used, however, some staples could not be formed and the staple line was incomplete centrally.The staple line was sutured.Another reload was used to complete the case.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one photograph of one device.A visual inspection of the returned photo noted that the only the jaws of the reload can be seen.The jaws can be seen open.The cartridge cannot be seen in the returned photographs.No device abnormalities can be seen.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.A definitive root cause could not be determined with regard to the reported condition.Without the physical product, a definitive root cause could not be identified.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 9980700
• Report Number: 2647580-2020-01388
• Device Sequence Number: 19751981
• Product Code: GDW
• UDI-Device Identifier: 10884523002942
• UDI-Public: 10884523002942
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 030416
• Device Catalogue Number: 030416
• Device Lot Number: P7A0885MX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR