MAUDE Adverse Event Report: TELEFLEX MEDICAL WECKVISTA ACCESS BALLOON PORT 12MMX100MM; LAPAROSCOPE, GENERAL & PLASTIC

Catalog Number 412944L

Device Problem Burst Container or Vessel (1074)

Patient Problems Laceration(s) (1946); No Consequences Or Impact To Patient (2199)

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The facility has communicated that the device is not available for evaluation.The device history review for the product weckvista access balloon port 12mmx100mm lot #73b1700367 investigation did not show issues related to the complaint.Corrective actions cannot be established, the customer complaint cannot be confirmed, and the root cause cannot be determined since it is necessary to receive the physical sample to perform a proper investigation and to confirm the alleged defect.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the event occurred during a laparoscopic distal gastrectomy.Even though the patient's skin was covered with the gauze in order to avoid patient damage, when the user inclined the inserted trocar to the patient's side, the contact with the clamp caused the laceration on the patient's skin.As a result of this issue, the wound was sutured by the physician.The user also says that the balloon of the trocar lasted only a few hours.Additionally, the user pointed out that the foam cuff's abnormally positioning is the design defect, which caused the product comes in contact with a patient's skin.There is no sample to for investigation because it was discarded in the hospital.

• Brand Name: WECKVISTA ACCESS BALLOON PORT 12MMX100MM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 7626532
• MDR Text Key: 111995788
• Report Number: 3003898360-2018-00512
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/19/2018

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 Expiration Date: 02/17/2019
• Device Catalogue Number: 412944L
• Device Lot Number: 73B1700367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2018
• Initial Date FDA Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention