MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN LAPRO-CLIP; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	8886848701
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/12/2019
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 laparoscopic cholecystectomy, clipping was performed, but the tip did not open.The procedure was completed with another device.

• Brand Name: LAPRO-CLIP
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8751141
• Report Number: 1219930-2019-03875
• Device Sequence Number: 2338845
• Product Code: GCJ
• UDI-Device Identifier: 10884521201941
• UDI-Public: 10884521201941
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K925602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2019

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 Model Number: 8886848701
• Device Catalogue Number: 8886848701
• Device Lot Number: C2015H081M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1