MAUDE Adverse Event Report: US SURGICAL PUERTO RICO MULTIFIRE ENDO HERNIA; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	174007
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.Visual inspection of the first instrument noted the e-piece was partially disengaged from the device on one side.There was evidence of weld on the device.One tack was jammed in the e piece.The single use loading unit (sulu) was received preloaded with three staples remaining.The tack was removed from the e piece of the first instrument.The first instrument was then applied to the appropriate test media.The handle was actuated and the first tack deployed improperly and did not seat properly due to the disengaged e-piece.Visual inspection of the second instrument noted there was a tack jammed in the e piece.No sulu was received.The tack was removed from the second instrument.A test sulu was then loaded onto the second instrument.The second instrument and loading unit were applied to the appropriate test media.The tacks deployed and seated properly in the test media.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the reported condition may occur as a result of excessive manipulation of the device.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.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during right inguinal hernia, while closing peritoneum, staples could not fire from stapler.It was as if they jammed at exit from stapler.Surgeon attempted to remove the cluster of staples to clear it but was unable to untangle.No patient injury.

• Brand Name: MULTIFIRE ENDO HERNIA
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 9931764
• Report Number: 2647580-2020-01243
• Device Sequence Number: 2561067
• Product Code: GCJ
• UDI-Device Identifier: 10884521070547
• UDI-Public: 10884521070547
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K912097
• 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
• Report Date (Section B): 04/06/2020

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 Model Number: 174007
• Device Catalogue Number: 174007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1