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

Model Number 8886848813

Device Problems Mechanical Problem (1384); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, intra-operatively, the device was loaded normally.After entering the patient, the clip fell off, unable to clamp.

Manufacturer Narrative

Summary of investigation post market vigilance (pmv) led an evaluation of two devices.The two cartridges were received not applied.The clips inside the cartridges were broken in pieces.Foil was inspected with light assisted microscopy with no abnormalities.The condition of the cartridges precludes functional evaluation.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all medtronic quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Replication of the broken clips inside the cartridges may occur when the packaging has been compromised and the product was left exposed to the environment causing the material to degrade.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported.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.

Manufacturer Narrative

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

Manufacturer Narrative

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 NORTH HAVEN - MFG; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN NORTH HAVEN - MFG; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7135170
• MDR Text Key: 95730508
• Report Number: 1219930-2017-10243
• Device Sequence Number: 1
• Product Code: GCJ
• 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,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/23/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 8886848813
• Device Catalogue Number: 8886848813
• Device Lot Number: N4B0519X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 02/22/2018; 02/22/2018; 02/22/2018
• Supplement Dates FDA Received: 03/14/2018; 03/21/2018; 03/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2014
• 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