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

Model Number 8886848813

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2023

Event Type  malfunction  

Event Description

According to the reporter, during a laparoscopic cholecystectomy, when the blood vessel was clamped, the clip could not be closed.A new clip was used to resolve the issue.There was no patient injury.

Manufacturer Narrative

Concomitant product: 8886848813, 8886848813 laproclip 2x12 x10 (lot#n2f0246y) 8886848813, 8886848813 laproclip 2x12 x10 (lot#n2f0246y) 8886848813, 8886848813 laproclip 2x12 x10 (lot#n2f0246y) unk laprocl ins, unknown lapro-clip instrument (lot#unknown).If information is provided in the future, a supplemental report will be issued.

• Brand Name: LAPRO-CLIP
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 16714668
• MDR Text Key: 313241464
• Report Number: 1219930-2023-01444
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521057661
• UDI-Public: 10884521057661
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K925602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2023

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
• Device Operator: Health Professional
• Device Model Number: 8886848813
• Device Catalogue Number: 8886848813
• Device Lot Number: N2F0246Y
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/11/2023
• Date Device Manufactured: 06/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1