ENDOCATCH *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-17 for ENDOCATCH * manufactured by Covidien, Llc.

Event Text Entries

[5845951] While performing a cancer staging procedure laparoscopically, a piece of omentum was taken and placed in an endocatch bag. It was left inside the patient with the intent of retrieving it later, as it was too large to be delivered through the assist port, and was going to be removed vaginally. The specimen was moved aside while the rest of the procedure was performed. The strings that remain outside the trocar were likely cut accidentally, and retracted into the patient who was then placed in steep trendelenburg and had a robotically assisted hysterectomy. Although the abdomen was irrigated, the specimen was not seen, as it presumably migrated under an organ. Consequently, the omentum specimen was not retrieved as intended at the end of the long case, and this was not discovered until the patient was in the pacu. As a result of this incident, we have implemented changes in our practice to prevent similar events; however, we would recommend that covidien add a radiopaque strip if possible to the endocatch bags as an additional safety measure so that the bags can be detected when the patient is wanded at the end of the procedure before the skin is closed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4855731
MDR Report Key4855731
Date Received2015-06-17
Date of Report2015-06-17
Report Date2015-06-17
Date Reported to FDA2015-06-17
Date Reported to Mfgr2015-06-19
Date Added to Maude2015-06-19
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameENDOCATCH
Generic NameLARYNGOSCOPE, ENDOSCOPE, SPECIMEN RETRIEVAL BAG
Product CodeCAL
Date Received2015-06-17
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorPHYSICIAN
Device AvailabilityN
Device Age*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN, LLC
Manufacturer Address15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048


Patients

Patient NumberTreatmentOutcomeDate
10 2015-06-17

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