MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ENDOPOUCH; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number POUCH 10MM

Device Problem Entrapment of Device (1212)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2016

Event Type  malfunction  

Event Description

When resident surgeon attempted to deploy endo-pouch, the thread that pulls through to deploy pouch caught or tangled in device.Resident surgeon and faculty surgeon manually released pouch, cut thread, and enveloped specimen.Faculty surgeon sequestered device.

• Brand Name: ENDOPOUCH
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 4545 creek rd.; cincinnati, OH 45242
• MDR Report Key: 5747749
• MDR Text Key: 48105307
• Report Number: 5747749
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/03/2016
• Device Model Number: POUCH 10MM
• Device Lot Number: N4LG01
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 134