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

Model Number IPN004939

Device Problem Material Fragmentation (1261)

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

Event Date 11/09/2022

Event Type  malfunction  

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 robotic hysteroannessectomy, during the extraction of the endobag with the sentinel lymphonode, the apex of the guide detached from the bag which is immediately recovered and extracted it appears intact.The was no reported injury.

Manufacturer Narrative

(b)(4).A visual, dimensional, or functional inspection could not be performed because the defective device is unavailable.Inspections during production: wire is assembled according to work instructions zwi-02-011, threaded through the bag according to work instruction zwi-02-005, glued on the inner side of the bag according to work instruction zwi-02-006 and closure loop was created according to work instruction zwi-02-007.Multifunction inspections of the wire, including both eyes, are performed during production and/or packaging of memobag products.In case of reported defect, such defect should be detected and immediately scrapped.The wire and protective tube of closure wire is 100% inspected several times during production.As the lot number of the defective product was reported, the device history review of the complained lot could be completed.Lot 71f22c1721 of 332800-000010 incoming inspection and final inspection records of raw material/semi-finished material were reviewed.Lots were checked by qc inspection and were released without a ny defect observed.There were no production issues from the perspective of the reported defect at the time of manufacture of the complained lot.Ifu prescribes "care should be taken at all times to avoid contact of the bag with sharp instruments, cutting devices, morcellators, electrocautery or laser delivery devices.To remove of memobag use graspers to grasp the closure loop located at the end of the closure wire.Retract the closure loop through the trocar to securely close the memobag, sealing the tissue inside.Continue to retract the closure loop until the memobag is at the base of the trocar.With the memobag at the base of the trocar, withdraw the trocar sheath, memobag and graspers until the closed mouth of the memobag is at the trocar incision site.Continue to remove the memobag through the trocar incision site by hand under direct vision.In the event that the procedure for removal is not fulfilled, the defect "broken wire" can be caused.The reported defect cannot be confirmed because the defective device was not returned for examination.The root cause of this complaint cannot be clearly determined because of unavailable defective device.No corrective or preventive actions in production are deemed necessary to introduce.

Event Description

It was reported that during the robotic hysteroannessectomy, during the extraction of the endobag with the sentinel lymphonode, the apex of the guide detached from the bag which is immediately recovered and extracted it appears intact.The was no reported injury.

Manufacturer Narrative

(b)(4).Received defective sample was packed in double pe bags.Pusher and sheath tubes were missing.It is visible that the bag is undamaged, closure wire is threaded through all drilled holes, end of closure wire glued to the bag through covering 8mm white tube without damaging, end of closure wire creating loop is damaged.Covering 18mm white tube is partially moved from original position.This tube is cut through the entire length.It was very easy to remove the 18mm long tube from the closure wire as no traces of glue were presented.The reported defect the apex of the guide detaches from the bag can be confirmed.Covering 18mm white tube was not glued to the end of closure wire so it was not fixed and could detach.Wire is assembled, threaded through the bag, closure loop created, and the covering 18mm long tube is glued to the wire loop all according to work instructions.Multifunction inspections of wire including both eyes are performed during production and/or packaging of memobag products.In case of reported defect, such defect should be detected and immediately scrapped.The wire including both eyed is 100% inspected during production.As the lot number of the de fective product was reported, the device history review revealed no production issues from the perspective of the reported defect at the time of manufacture of the complained lot.The root cause of cutting covering tube through the entire length was not identified.An nc was opened to identify the root cause of this manufacturing issue of missing glue.

Event Description

It was reported that during the robotic hysteroannessectomy, during the extraction of the endobag with the sentinel lymphonode, the apex of the guide detached from the bag which is immediately recovered and extracted it appears intact.The was no reported injury.

• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15915207
• MDR Text Key: 307903509
• Report Number: 3006425876-2022-01073
• Device Sequence Number: 1
• Product Code: KGY
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN004939
• Device Catalogue Number: 332800-000010
• Device Lot Number: 71F22C1721
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 12/15/2022; 02/10/2023
• Supplement Dates FDA Received: 01/05/2023; 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2022
• 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: NONE REPORTED; NONE REPORTED; NONE REPORTED
• Patient Age: 59 YR