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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 Problem Entrapment of Device (1212)
Patient Problem No Code Available (3191)
Event Date 05/09/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Batch # unknown. The lot/batch was not provided; therefore, the manufacturing records could not be reviewed. Additional information received: pouch functioned properly. It was left in the abdominal cavity. Ct done post op confirmed pouch by air fluid levels. Patient brought back to or same day to remove pouch. Same post op care. Additional information requested and received: what was the approximate size of the ovarian cyst that was placed in the pouch? was the cyst drained or did it remain intact during the removal? was excessive force required during removal in the first procedure? did the surgeon enlarge the fascia of the removal site? did the pouch fall off the metal arms? did any portion of the pouch break and come apart? it was reported that the pouch was discarded and not returning. Are pictures available of the pouch after it was removed in the re-op? response: unfortunately, no further information is available.

 
Event Description

It was reported that during a robotic ovarian cystectomy, during pouch removal. Pouch is believed to be retained within the patient. A ct scan was done, and the pouch was shown and successfully removed. There were no patient consequences reported.

 
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Brand NameENDOPOUCH RETRIEVER SPEC BAG
Type of DeviceLAPAROSCOPE, 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 Key8713521
MDR Text Key148468561
Report Number3005075853-2019-19873
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
PMA/PMN NumberK011501
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 06/06/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/19/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPOUCH
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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