MAUDE Adverse Event Report: TELEFLEX MEDICAL EXTRACTION BAG FOR MIS

Model Number IPN004939

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Information (3190)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that during the extraction of the operating piece(gallbladder)the bottom of the bag tore.Bile and a gallstone were thus spilled into the abdominal cavity.Clinical consequences: it was necessary to perform a mini laparotomy to recover the stone and wash the abdominal cavity.

Event Description

It was reported that during the extraction of the operating piece(gallbladder)the bottom of the bag tore.Bile and a gallstone were thus spilled into the abdominal cavity.Clinical consequences: it was necessary to perform a mini laparotomy to recover the stone and wash the abdominal cavity.

Manufacturer Narrative

(b)(4).Corrected catalog/lot#: 332800-000010/71f19j0658.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 manufacture of the complained lot.The reported defect cannot be confirmed because the defective device was not returned for examination.Ifu 940268-000000 says that large tissue specimens may need to be cut into smaller pieces for removal.Furthermore, it says that the memobag is removing through the trocar incision side.If the contents of the memobag are too larger to pass through the trocar incision, the incision may need to be enlarged to facilitate removal of the memobag./fu 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.In the event, that one of above issues is not fulfilled, the complained defect (broken bag) can be caused.The root cause of this complaint cannot be determined because of unavailable defective device and lack of information about defect from the customer.As the root cause of this complaint was not determined, 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: 9496937
• MDR Text Key: 172208510
• Report Number: 3006425876-2019-01087
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN004939
• Device Catalogue Number: 332800-000010
• Device Lot Number: 71F19J0658
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention