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U.S. Department of Health and Human Services

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

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COVIDIEN LP LLC NORTH HAVEN LAPRO-CLIP LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 8886848813
Device Problems Failure to Fire (2610); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/10/2020
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 an open radical gastrectomy, the clip did not open, it was closed before installing on the applier, the clip applier was not able to fire at all. A new device was used to resolve the issue and complete the case. There was no patient injury.

 
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Brand NameLAPRO-CLIP
Type of DeviceLAPAROSCOPE, 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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key10454059
MDR Text Key204370618
Report Number1219930-2020-03528
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK925602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 11/03/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/26/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number8886848813
Device Catalogue Number8886848813
Device LOT NumberN9C0692Y
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/09/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/02/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/14/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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