MAUDE Adverse Event Report: TELEFLEX MEDICAL EXTRACTION BAG FOR MIS

Catalog Number 332800-000010

Device Problems Break (1069); Device Fell (4014)

Patient Problem No Information (3190)

Event Date 07/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The facility has communicated that the device is not available for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that during a cholecystectomy by laparoscopy, use of an extraction bag to remove the piece through the umbilical orifice.During removal of the bag (5 mm right flank trocar to 10 mm umbilical trocar), the closure loop of the bag broke leaving a piece of plastic and a piece of metal in the abdomen.The end of the traction wire remained in the abdomen.The plastic part is removed secondarily with a clamp.Clinical consequences: the metallic has not been retrieve despite an attempt was made to remove it through the right flank trocar opening, scope, and local exploration.

Event Description

It was reported that during a cholecystectomy by laparoscopy, use of an extraction bag to remove the piece through the umbilical orifice.During removal of the bag (5 mm right flank trocar to 10 mm umbilical trocar), the closure loop of the bag broke leaving a piece of plastic and a piece of metal in the abdomen.The end of the traction wire remained in the abdomen.The plastic part is removed secondarily with a clamp.Clinical consequences: the metallic has not been retrieve despite an attempt was made to remove it through the right flank trocar opening, scope, and local exploration.

Manufacturer Narrative

(b)(4).Customer complaint regarding memobag product was reported.As the lot number of the defective product was reported, the dhr review was completed.The review of dhr revealed no production issues at the time of manufacturing of the complained lot.Returned defective sample was examined and the reported defect can be confirmed.Ifu 940268-000000 says that the care should be taken at all times to avoid contact of the bag with sharp instruments, cutting devices, morcellators, electrocautery or laser delivery devices.The ifu prescribed that to remove of memobag, use graspers to grasp the closure loop located at the end of the closure wire.The root cause of this complaint was determined as improper manipulation with the bag during bag removal - ifu was not followed during bag removal.As the root cause was determined improper method of use (improper removal of the bag), no corrective/preventive actions in production are deemed necessary to introduce.

• Brand Name: EXTRACTION BAG FOR MIS
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8866027
• MDR Text Key: 153505573
• Report Number: 3006425876-2019-00559
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 332800-000010
• Device Lot Number: 71F19C2872
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/06/2019
• Supplement Dates Manufacturer Received: 09/04/2019
• Supplement Dates FDA Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention