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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 UNKNOWN LAPRO-CLIP INSTRUMENT
Device Problems Disassembly (1168); Device Difficult to Setup or Prepare (1487); Failure to Fire (2610)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2018
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 a laparoscopic lobectomy, when dealing with the blood vessels, the device was difficult to assemble and disassemble and there were issues with the clip or clip cartridge.At the same time clips won't release from the device and won't form correctly they replaced the product to complete the case.There was no patient injury.
 
Manufacturer Narrative
This event has been reassessed and found to be a non-mdr reportable complaint.If information is provided in the future, a supplemental report will be issued.
 
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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
MDR Report Key7663587
MDR Text Key113179237
Report Number1219930-2018-03593
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUNKNOWN LAPRO-CLIP INSTRUMENT
Device Catalogue NumberUNKNOWN LAPRO-CLIP INSTRUMENT
Was Device Available for Evaluation? No
Date Manufacturer Received06/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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