MAUDE Adverse Event Report: TELEFLEX MEDICAL HORIZON TI MED 6/CART 180/BOX; CLIP, IMPLANTABLE

Catalog Number SURGICAL UNKNOWN

Device Problem Failure to Eject (4010)

Patient Problem Insufficient Information (4580)

Event Date 11/03/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

This problem has occurred several times without consequence for patients.Each time we changed the applier.Update and clarification: the customer replied that he was not able to provide any other information with regards to other incidents that would have happened previously.So, the catalog number has been changed to surgical unknown as, as per additional information received, it's unknown what the involved device was, so unknown if an applier or a clip was involved in another incident.As the customer is not able to provide additional information, no catalog number can be assigned to the complaint and no other information will be received.Initial event report: incident happened on the (b)(6) 2021 in surgery room.During a thyroid surgery the doctor had to use a blue titanium clip ref 002200 lot 73j2000654.The clip did not hold on the thyroid artery.This clip got stuck on one of the jaws the horizon medium clip pliers 237081 lot 06k1757772.

Event Description

This problem has occurred several times without consequence for patients.Each time we changed the applier.Update and clarification: the customer replied that he was not able to provide any other information with regards to other incidents that would have happened previously.So, the catalog number has been changed to surgical unknown as, as per additional information received, it's unknown what the involved device was, so unknown if an applier or a clip was involved in another incident.As the customer is not able to provide additional information, no catalog number can be assigned to the complaint and no other information will be received.Initial event report: incident happened on the 20 october 2021 in surgery room.During a thyroid surgery the doctor had to use a blue titanium clip ref 002200 lot 73j2000654.The clip did not hold on the thyroid artery.This clip got stuck on one of the jaws the horizon medium clip pliers 237081 lot 06k1757772.

Manufacturer Narrative

(b)(4).Dhr review could not be conducted since the lot number was not provided.Revision of d000761 rev 05 was performed and the failure mode is already including it, no update is required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.

• Brand Name: HORIZON TI MED 6/CART 180/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12857280
• MDR Text Key: 281148357
• Report Number: 3003898360-2021-01046
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: MN
• PMA/PMN Number: K132658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SURGICAL UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1