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

Model Number	174015
Medical Device Problem Codes	Detachment Of Device Component (1104); Misfire (2532); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, while closing the peritoneum during a laparoscopic inguinal hernia procedure on (b)(6) 2017,the device partially fired but was difficult to load.Some staple loaders fell into the patient's cavity but all have been retrieved by the surgeon during the surgery.The surgeon used 3 loaders with the same device to complete the peritoneum closure.There was no patient injury.
Additional Manufacturer Narrative
Correction: evaluation summary: post market vigilance (pmv) led an evaluation of three devices.One device has a disengaged spring and broken bridge.The other two devices showed no abnormalities.All three devices were fully fired.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 disengaged spring may occur if excessive force is applied when removing the device from an endo hernia instrument.When excessive force is applied the bridge which holds the spring in place can break allowing the spring to disengage.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• 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: 6986912
• Report Number: 2647580-2017-07435
• Device Sequence Number: 13720443
• Product Code: GCJ
• UDI-Device Identifier: 20884521070551
• UDI-Public: 20884521070551
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K912097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2018

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: 04/30/2021
• Device Model Number: 174015
• Device Catalogue Number: 174015
• Device Lot Number: P6D0384X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1