MAUDE Adverse Event Report: TELEFLEX MEDICAL EXTRACTION BAG FOR MIS

Catalog Number 332800-000010

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (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 upon inserting the user found a cut line on the bag.Therefore, another extraction bag was used instead.

Manufacturer Narrative

Qn# (b)(4).Customer complaint regarding memobag product was reported.As the lot number of the defective product was not reported, the dhr review was not completed.The reported defect cannot be confirmed because the defective device was not returned for examination.Ifu (b)(4) 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.Ifu says that the care should be taken at all times to avoid contact of the bag with sharp instruments, cutting devices, morcellators, e/ectrocautery 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 clearly determined because of unavailable defective device and lack of information about reported defect.As the root cause of this complaint was not determined, no corrective/preventive actions in production are deemed necessary to introduce.

Event Description

It was reported that upon inserting the user found a cut line on the bag.Therefore, another extraction bag was used instead.

• Brand Name: EXTRACTION BAG FOR MIS
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11101473
• MDR Text Key: 225806838
• Report Number: 3006425876-2020-01120
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 332800-000010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1