MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN POLY SURGICLIP; CLIP, IMPLANTABLE

Model Number	133649
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2018
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 procedure, the device experienced issue with the loading/firing of the clips.A second product had to be opened and used to complete the case.There was no patient harm.

• Brand Name: POLY SURGICLIP
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8127314
• Report Number: 1219930-2018-06468
• Device Sequence Number: 16217135
• Product Code: FZP
• UDI-Device Identifier: 10884521133679
• UDI-Public: 10884521133679
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K900122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/03/2018

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 Model Number: 133649
• Device Catalogue Number: 133649
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1