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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO - SURGERY ETHICON ENDOPOUCH SPECIMEN RETRIEVAL BAG; LAPAROSCOPE
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ETHICON ENDO - SURGERY ETHICON ENDOPOUCH SPECIMEN RETRIEVAL BAG; LAPAROSCOPE Back to Search Results
Device Problem Break (1069)
Patient Problems Pain (1994); Rupture (2208); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Event Date 02/12/2018
Event Type  Injury  
Event Description
Pt had a diagnostic laparoscopy, and right cystectomy on (b)(6) 2018, utilizing ethicon endopouch specimen retrieval device.The cyst had ruptured and the device was used to collect the pieces of the cyst.The bag did break in the process of removing the device, but the surgeon thought all of the pieces of the bag were removed.Pt returned to the hospital on (b)(6) 2018 with complaints of pain and fullness in llq for laparoscopy, reduction and closure of incarcerated acute post op port site hernia, repair of bowel injury, removal of retained foreign body (a piece of the ethicon endopouch specimen retrieval bag.).
 
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Brand Name
ETHICON ENDOPOUCH SPECIMEN RETRIEVAL BAG
Type of Device
LAPAROSCOPE
Manufacturer (Section D)
ETHICON ENDO - SURGERY
MDR Report Key7472009
MDR Text Key106957481
Report NumberMW5076851
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 Other Health Care Professional
Type of Report Initial
Report Date 04/13/2018
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
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/27/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age33 YR
Patient Weight105
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