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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 Detachment of Device or Device Component (2907)
Patient Problems Tissue Damage (2104); Peritonitis (2252); Injury (2348); Foreign Body In Patient (2687); No Code Available (3191)
Event Date 11/03/2018
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

According to the reporter, during a laparoscopic cholecystectomy, while the device was being applied on the cystic duct, the clips fell into patient cavity and were not retrieved. The device component fell into the patient cavity and was retrieved. There was an unanticipated tissue loss and tissue damage as a result of the problem. Choleric peritonitis and secondary laparotomy were needed. The patient was transferred to a superior hospital for a secondary open surgery conversion. The patient hospitalization was extended for eleven days. The incision was extended by more than 1 inch to complete the case. There was permanent 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 Key8339353
MDR Text Key136139691
Report Number1219930-2019-00881
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
Report Date 03/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/14/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number8886848813
Device Catalogue Number8886848813
Device LOT NumberN8C1265X
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 Received03/04/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/29/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/14/2019 Patient Sequence Number: 1
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