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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPOUCH RETRIEVER SPEC BAG; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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ETHICON ENDO-SURGERY, LLC. ENDOPOUCH RETRIEVER SPEC BAG; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Catalog Number POUCH
Device Problems Material Split, Cut or Torn (4008); Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/08/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Batch # unknown.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.
 
Event Description
It was reported that during an unknown procedure, the pouch tore, and the specimen fell back into the patient.Case completed with another device of the same product code.There were no patient consequences reported.
 
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Brand Name
ENDOPOUCH RETRIEVER SPEC BAG
Type of Device
LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
Manufacturer (Section G)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
Manufacturer Contact
milton garrett
475 calle c
guaynabo 00969
5133378865
MDR Report Key8830549
MDR Text Key152537521
Report Number3005075853-2019-20777
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier10705036012986
UDI-Public10705036012986
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011501
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPOUCH
Was Device Available for Evaluation? No
Date Manufacturer Received07/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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