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

Model Number	8886848882
Medical Device Problem Codes	Mechanical Problem (1384); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2019
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 laparoscopic partial nephrectomy, the device did not clamp well, the clamping force was weak.The procedure was completed with another device.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual examination of the cartridge noted that the clip was fully formed but not completely deployed from the cartridge.Since the clinical instrument was not received the loading unit was loaded into a pmv representative instrument and fired; the pusher advanced properly and deployed the clip.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 clip not fully deployed condition may occur if the trigger of the instrument is not fully actuated releasing the clip from the cartridge.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• 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: 8814561
• Report Number: 1219930-2019-04331
• Device Sequence Number: 2838943
• Product Code: GCJ
• UDI-Device Identifier: 10884521057678
• UDI-Public: 10884521057678
• 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,Followup
• Report Date (Section B): 10/03/2019

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: 8886848882
• Device Catalogue Number: 8886848882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1