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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 8886848882
Device Problem Failure to Fire (2610)
Patient Problem No Patient Involvement (2645)
Event Date 07/07/2020
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

According to the reporter, pre operatively, on a hepatectomy, the reload did not fire. The user changed to a new reload to resolve the issue. There was no patient involvement.

 
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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 Key10331923
MDR Text Key200604424
Report Number1219930-2020-03035
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeTW
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
Report Date 07/28/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/28/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number8886848882
Device Catalogue Number8886848882
Device LOT NumberN8L0306Y
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/09/2018
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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