MAUDE Adverse Event Report: TELEFLEX MEDICAL WECKVISTA INSUFFLATION NDL 14GA 120MM; INSUFFLATOR, LAPAROSCOPIC

Catalog Number	35120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "needle broke off while in patient".No patient harm or injury.The patient status is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.
Additional Manufacturer Narrative
(b)(4).Additional information received 13-nov-2024 states "no parts fell into the patient, and it was resolved eventually by finding a device that worked".The customer returned one unit of 35120 weckvista insufflation ndl 14ga 120mm for investigation.The needle was returned unsealed without its original packaging.The needle was observed to be not broken.The base of the needle body was broken off the stopcock/port component.R & d engineering was consulted as part of this investigation.R & d determined that the damage observed on the needle indicates that unintentional user error caused or contributed to this event.A device history record review was performed and no relevant findings were identified.The ifu for this product states, "insert the weck vista insufflation needle assembly through the abdominal wall using continuous , controlled, slow, forward motion." the reported complaint was confirmed based upon the sample received.The needle was returned in a severely damaged state.The base of the needle body was broken off the stopcock/port component.R & d determined that the damage observed on the needle indicates that unintentional user error caused or contributed to this event.The customer confirmed that the breakage occurred during use, that there was no packaging damage, and that the sample was received with a correctly assembled needle cover.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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "needle broke off while in patient".No patient harm or injury.The patient status is reported as "fine".

• Brand Name: WECKVISTA INSUFFLATION NDL 14GA 120MM
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20674544
• Report Number: 3003898360-2024-01432
• Device Sequence Number: 13009119
• Product Code: HIF
• UDI-Device Identifier: 04026704418671
• UDI-Public: (01)04026704418671(11)231201(17)261130(10)73L2300901(21)
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K003703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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: 35120
• Device Lot Number: 73L2300901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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