MAUDE Adverse Event Report: TELEFLEX MEDICAL EXTRACTION BAG FOR MIS

Model Number IPN004939

Device Problem Material Rupture (1546)

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

Event Date 03/07/2021

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

Involved a (b)(6) year-old female patient.During a surgery for a laparoscopic cholecystectomy because of a hyperalgesic hydrocholecyst.At the end of the procedure, during the removal of the gallbladder from the abdomen, the bag ruptured.The surgeon managed to finish the procedure and to remove the gallbladder but still the gallbladder touched the abdomen wall before being removed.Specimen was recovered.Exams performed results say there is no cancerous content.

Event Description

Involved a 29 year-old female patient.During a surgery for a laparoscopic cholecystectomy because of a hyperalgesic hydrocholecyst.At the end of the procedure, during the removal of the gallbladder from the abdomen, the bag ruptured.The surgeon managed to finish the procedure and to remove the gallbladder but still the gallbladder touched the abdomen wall before being removed.Specimen was recovered.Exams performed results say there is no cancerous content.

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 manufacture of the complained lot.The defective device was returned for examination.Reported defect can be confirmed.One hole/rupture was found in the bottom part of memobag.Such hole i rupture cannot be found after bag insertion and opening depending on character of the hole/rupture.The hole/rupture was created from the inside out.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.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 this complaint was determined as improper method of use during memobag removal depending on character of found defect.The hole i rupture was created from the inside out.As the root cause of this complaint was determined improper method of use, 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: 11604317
• MDR Text Key: 244704375
• Report Number: 3006425876-2021-00277
• 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
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

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: 71F20L2861
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/01/2021
• Supplement Dates Manufacturer Received: 05/04/2021
• Supplement Dates FDA Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR