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

Model Number	8886848812
Medical Device Problem Codes	Mechanical Problem (1384); Device Slipped (1584)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2018
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 laparoscopic cholecystectomy procedure, while clipping the cystic duct, the device¿s clip did not hold tight, wherein the clips were too soft.The clips were able to disengage from the cartridge.And the clip cartridge was able to be properly loaded onto the handle.The clips were not able to form correctly.No patient injury.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of one box of six devices.The cartridges were received sealed.Foil was inspected with light assisted microscopy with no abnormalities.No visual abnormalities were observed.Functionally; a pmv representative instrument was used for all functional testing.The cartridges were loaded into the pmv representative instrument, the firing handle was actuated multiple times, and all the clips formed properly onto the test media.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.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.
Event or Problem Description
According to the reporter, during a laparoscopic cholecystectomy procedure, while clipping the cystic duct, the device¿s clip did not hold tight, wherein the clips were too soft.The clips were able to disengage from the cartridge.And the clip cartridge was able to be properly loaded onto the handle.The clips were not able to form correctly.A new device was used in order to complete the case.No patient injury.

• 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: 7280783
• Report Number: 1219930-2018-00913
• Device Sequence Number: 1211888
• Product Code: GCJ
• UDI-Device Identifier: 20884521057651
• UDI-Public: 20884521057651
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K925602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018

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: 05/31/2022
• Device Model Number: 8886848812
• Device Catalogue Number: 8886848812
• Device Lot Number: N7E0662X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 02/19/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1