MAUDE Adverse Event Report: US SURGICAL PUERTO RICO PREMIUM SURGICLIP; CLIP, IMPLANTABLE

Model Number	134046
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2019
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 coronary artery bypass surgery, the device got stuck after firing a few clips.They tried to use two devices of the same product id but still they experienced the same situation.A fourth device of the same product id was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of three devices.The first instrument was received partially applied with three remaining clips.The second instrument was received partially applied with four remaining clips.Visual inspections of the instruments revealed no abnormalities.Functionally, the instruments were fired once in air and proper clip formation was confirmed.The remaining clips were then fired on test media with proper formations.The jaws and handles moved smoothly through their firing cycles and returned to the open positions and each remaining clip loaded properly in the jaws.When the cartridges were empty, the interlocks engaged and prevented the jaw from approximating.The third instrument was received fully applied.Visual inspection of the instrument revealed no abnormalities.Functionally, the empty cartridge precludes firing evaluation; however, the interlock was engaged and properly prevented the jaw from approximating.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PREMIUM SURGICLIP
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8520723
• Report Number: 2647580-2019-02044
• Device Sequence Number: 11170014
• Product Code: FZP
• UDI-Device Identifier: 10884521057548
• UDI-Public: 10884521057548
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K853650
• 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): 09/04/2019

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: 02/28/2023
• Device Model Number: 134046
• Device Catalogue Number: 134046
• Device Lot Number: P8B1070CX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1