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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN - MFG ENDO PEANUT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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COVIDIEN NORTH HAVEN - MFG ENDO PEANUT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 173019
Medical Device Problem Codes Detachment Of Device Component (1104); Melted (1385)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/15/2017
Type of Reportable Event Malfunction
Event or Problem Description
According to the reporter, during a laparoscopic cholecystectomy, while the intraoperative intra-abdominal preparation, the swab dissolved and fell into the abdomen.The swab was retrieved.There was no patient injury.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
ENDO PEANUT
Common Device Name
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
COVIDIEN NORTH HAVEN - MFG
195 mcdermott road
north haven CT 06473
MDR Report Key6489998
Report Number1219930-2017-05285
Device Sequence Number13657027
Product Code GCJ
UDI-Device Identifier20884523000761
UDI-Public20884523000761
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
K931962
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 02/21/2017
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
Operator of Device Health Professional
Device Expiration Date11/30/2020
Device Model Number173019
Device Catalogue Number173019
Device Lot NumberM5L01X
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/21/2017
Supplement Date Received by Manufacturer02/21/2017
Initial Report FDA Received Date04/13/2017
Supplement Report FDA Received Date10/03/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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