MAUDE Adverse Event Report: TELEFLEX MEDICAL EXTRACTION BAG FOR MIS; BAG, INTESTINE

Model Number IPN004941

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 07/06/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.

Event Description

Bag broke during use - kidney removal.No reported injury.

Event Description

Bag broke during use - kidney removal.No reported injury.

Manufacturer Narrative

(b)(4).2 customer complaints regarding memobag product were reported.As the lot number of the defective product was reported, the dhr review was completed.The review of ohr revealed no production issues at the time of manufacture of the complained lot.The reported defect cannot be confirmed because the defective devices were 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, 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 these complaints cannot be clearly determined because of unavailable defective devices.As the root cause of these complaints was not determined, no corrective/preventive actions in production are deemed necessary to introduce.

• Brand Name: EXTRACTION BAG FOR MIS
• Type of Device: BAG, INTESTINE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15068087
• MDR Text Key: 300895550
• Report Number: 3006425876-2022-00666
• Device Sequence Number: 1
• Product Code: KGY
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN004941
• Device Catalogue Number: 332800-000030
• Device Lot Number: 71F22A1712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: N/A.