MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ETHICON ENDO-SURGERY, LLC; ENDOPOUCH RETRIEVER 26CM, 10MM

Model Number 26CM/10MM POUCH

Device Problem Failure to Fire (2610)

Patient Problem No Information (3190)

Event Date 04/25/2016

Event Type  Injury  

Event Description

During laparoscopic cholecystostomy, an endopouch retriever was inserted into the abdomen through a trocar.When the surgeon attempted to fire it, to discharge the endopath, it did not feel right.When fired, there was no string and no endopouch expelled from the tubular portion of the device.The device was handed off the field and broken open to determine if any of the components were retained within the tubular structure.None were found.A sweep surveillance of the abdomen was conducted; no components of the string and/or endopouch were found upon visual inspection.(there are no radiopaque components that could be found on x-ray.) the surgeon believes there are no retained components.The mfr is sending materials to return the instrument; we expect to ship it on thursday 04/28/2016.(b)(4).(b)(6).

• Brand Name: ETHICON ENDO-SURGERY, LLC
• Type of Device: ENDOPOUCH RETRIEVER 26CM, 10MM
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; somerville NJ 08876
• MDR Report Key: 5620359
• MDR Text Key: 44141307
• Report Number: MW5061977
• Device Sequence Number: 1
• Product Code: GCJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Model Number: 26CM/10MM POUCH
• Device Lot Number: N4L39J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 70