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

Model Number 8886848813

Device Problem Mechanics Altered (2984)

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

Event Date 05/11/2022

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during laparoscopic cholecystectomy, when trying to clip the cystic duct, the device could not be fired smoothly.When the device was removed from the cavity, the applier suddenly separated into several parts.Another applier was used to resolve the issue in order to complete the case.There was no patient injury.

• 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: covidien landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 14558216
• MDR Text Key: 293094289
• Report Number: 1219930-2022-02033
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521057661
• UDI-Public: 10884521057661
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K925602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• 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: N1B0312Y
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2022
• Date Device Manufactured: 02/11/2021
• 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
• Patient Age: 87 YR
• Patient Sex: Female