MAUDE Adverse Event Report: TELEFLEX MEDICAL WECKVISTA ACCESS BALLOON PORT 10MMX70MM; LAPAROSCOPE, GENERAL & PLASTIC

Model Number	IPN914248
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during robot-assisted surgery, a piece of the balloon was found detached from the trocar in the patient's abdomen.Unsuccessful extraction attempt, given the size of the detached piece.In the end, foreign body found trapped in another trocar.Consequences: longer operating time - laparoscopic search for the piece".Additional information received states that "it took 1 hour to recover all the parts from the balloon out of the patient.Patient is fine.All the pieces were recovered, but with a different trocar".
Event or Problem Description
It was reported that "during robot-assisted surgery, a piece of the balloon was found detached from the trocar in the patient's abdomen.Unsuccessful extraction attempt, given the size of the detached piece.In the end, foreign body found trapped in another trocar.Consequences: longer operating time - laparoscopic search for the piece." additional information received states that "it took 1 hour to recover all the parts from the balloon out of the patient.Patient is fine.All the pieces were recovered, but with a different trocar".
Additional Manufacturer Narrative
(b)(4).The customer returned one unit of 410944 weckvista access balloon port 10mmx70mm for investigation.The device was examined with and without magnification.The trocar and cannula were returned for this complaint.Visual examination of the returned sample revealed a ruptured balloon.One piece of the balloon was returned in a separate container, as it had been fully severed from the device.R & d was consulted for this complaint.R & d determined that balloon had ruptured from an inside force and was not cut from the outside.The cause of the rupture could not be determined, and no conclusive reason could be confirmed.Evidence of biomaterial was observed on the device.The reported complaint of "broken/detached parts - burst - balloon " was confirmed based upon the sample received.A device history record review was performed, and no relevant findings were identified.The customer returned one unit of 410944 weckvista access balloon port 10mmx70mm for investigation.The device was examined with and without magnification.The trocar and cannula were returned for this complaint.Visual examination of the returned sample revealed a ruptured balloon.One piece of the balloon was returned in a separate container, as it had been fully severed from the device.R & d was consulted for this complaint.R & d determined that balloon had ruptured from an inside force and was not cut from the outside.The cause of the rupture could not be determined, and no conclusive reason could be confirmed.Evidence of biomaterial was observed on the device.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: WECKVISTA ACCESS BALLOON PORT 10MMX70MM
• 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: 22046593
• Report Number: 3003898360-2025-00419
• Device Sequence Number: 8880303
• Product Code: GCJ
• UDI-Device Identifier: 04026704559756
• UDI-Public: (01)04026704559756(11)240121(17)260120(10)73A2400335(21)
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2026
• Device Model Number: IPN914248
• Device Catalogue Number: 410944
• Device Lot Number: 73A2400335
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown