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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 Problem Mechanics Altered (2984)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/30/2020
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 laparoscopic cholecystectomy, when the absorbable clip was used, it failed to pop out normally and clamped the tissue.Instead, the ligation clip was used to complete the operation.There was no patient injury.
 
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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
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 Key9987483
MDR Text Key188641556
Report Number1219930-2020-01834
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier10884521057661
UDI-Public10884521057661
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K925602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/22/2020
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 Date11/30/2022
Device Model Number8886848813
Device Catalogue Number8886848813
Device Lot NumberN7L0926X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/10/2020
Initial Date FDA Received04/22/2020
Date Device Manufactured11/22/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age74 YR
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