MAUDE Adverse Event Report: COVIDIEN/ MEDTRONIC INC. ENDOCATCH; RETRIEVAL POUCH

Model Number 173049

Device Problem Difficult to Open or Close (2921)

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

Event Date 12/15/2016

Event Type  malfunction  

Event Description

Patient to have laparoscopic left radical nephrectomy for left renal mass.Operative procedure indicates the surgeon proceeded to detach the kidney superiorly and laterally until it was completely mobilized off.At this juncture, he then removed the 12-mm lower trocar near the anterior superior iliac crest and inserted a large endocatch bag.The specimen was placed into the bag and tried to close the bag, but the bag would not fully close properly.The device was removed.At this point then, he proceeded to then close the other two ports with a carter-thomason endoscopic closure to enlarge the (incision) extraction site in the lower abdomen on the left side.The surgeon reached his hand in and grabbed the bag.The surgeon was able to deliver the specimen within the bag out of the patent's abdominal cavity and sent specimen for analysis.

• Brand Name: ENDOCATCH
• Type of Device: RETRIEVAL POUCH
• Manufacturer (Section D): COVIDIEN/ MEDTRONIC INC.; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 6218400
• MDR Text Key: 63759510
• Report Number: 6218400
• Device Sequence Number: 0
• Product Code: NWV
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 173049
• Device Catalogue Number: 173049
• Device Lot Number: J6H0936X
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: LAPROSCOPE
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 93