MAUDE Adverse Event Report: TELEFLEX MEDICAL WECKVISTA ACCESS BALLOON PORT 10MMX53MM; LAPAROSCOPE, GENERAL & PLASTIC

Catalog Number	410944S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the balloons burst.The devices have a balloon to unable the trocar to move during procedure.Nevertheless, twice, the balloon burst, and the trocar migrated outside the patient during procedure.They were replaced by a trocar from another reference.These incidents caused delay in the surgery, prolonging the surgery time".Additional information states, "the trocar completely went out the patient in both cases.One balloon completely deflated, the other was leaking.Apart from the laparoscopic scope, no instruments had been inserted through the trocar." no further information is available as the customer stated "as the event took place too long ago, some questions remain unanswered and the answers are unfortunately sometimes imprecise." if further information is received, the complaint file will be updated.See associated mdr #3003898360-2023-01537.
Additional Manufacturer Narrative
(b)(4) n/a other remarks: n/a corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "burst - balloon" could not be confirmed based upon the sample received.Upon functional inspection, no leak was observed.This was confirmed by r & d engineering.A dhr review was performed with no evidence to suggest a manufacturing related cause.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that "the balloons burst.The devices have a balloon to unable the trocar to move during procedure.Nevertheless, twice, the balloon burst, and the trocar migrated outside the patient during procedure.They were replaced by a trocar from another reference.These incidents caused delay in the surgery, prolonging the surgery time".Additional information states, "the trocar completely went out the patient in both cases.One balloon completely deflated, the other was leaking.Apart from the laparoscopic scope, no instruments had been inserted through the trocar." no further information is available as the customer stated "as the event took place too long ago, some questions remain unanswered and the answers are unfortunately sometimes imprecise." if further information is received, the complaint file will be updated.Associated mdr #3003898360-2023-01537.

• Brand Name: WECKVISTA ACCESS BALLOON PORT 10MMX53MM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18114313
• Report Number: 3003898360-2023-01538
• Device Sequence Number: 7016614
• Product Code: GCJ
• UDI-Device Identifier: 04026704559787
• UDI-Public: 04026704559787
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 410944S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2023
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown