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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LLC 10MM SPECIMEN RETRIEVAL BAG FROM COVIDIEN LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

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COVIDIEN LLC 10MM SPECIMEN RETRIEVAL BAG FROM COVIDIEN LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Catalog Number REF# 173050G
Device Problems Bag (553); Break (1069); Leak/Splash (1354)
Patient Problem No Code Available (3191)
Event Date 12/26/2019
Event Type  Injury  
Event Description

Specimen retrieval bag broke that had appendix obtained during laparoscopy procedure. Specimen fell back into abdomen and needed retrieved by another bag took more time and a potential contamination cavity product endo catch gold from covidien 10mm retrieval bag ref # 173050g fda safety report id # (b)(4).

 
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Brand Name10MM SPECIMEN RETRIEVAL BAG FROM COVIDIEN
Type of DeviceLAPAROSCOPE, GENERAL AND PLASTIC SURGERY
Manufacturer (Section D)
COVIDIEN LLC
MDR Report Key9538637
MDR Text Key173501557
Report NumberMW5091949
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/30/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/31/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberREF# 173050G
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/31/2019 Patient Sequence Number: 1
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