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

Model Number	030807L
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a video-assisted thoracic surgery (vats) wedge resection, the second unit was used and the tissue was clamped but not completely severed by the scalpel.It was reported that the scalpel was bent.Another stapler was used to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of one device.Nicks were observed on the knife blade and the knife blade was received severely bent.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Replication of the observed damage may occur if the instrument is applied over an obstruction.The instructions for use also states: when positioning the instrument on the application site ensure that no obstructions such as previously clips are incorporated into the instrument jaws.Firing over an obstruction may result in improperly formed staples.Improperly formed staples may result in leakage or disruption of the staple line.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MULTIFIRE 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: 8441916
• Report Number: 2647580-2019-01517
• Device Sequence Number: 1104583
• Product Code: GDW
• UDI-Device Identifier: 10884523003772
• UDI-Public: 10884523003772
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K900129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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: 05/31/2023
• Device Model Number: 030807L
• Device Catalogue Number: 030807L
• Device Lot Number: P8E1452MX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 81