MAUDE Adverse Event Report: TELEFLEX MEDICAL HZ APPLIER MED 8" CVD; APPLIER, SURGICAL, CLIP

Model Number IPN028188

Device Problem Separation Problem (4043)

Patient Problems Hemorrhage/Bleeding (1888); Nerve Damage (1979)

Event Date 10/20/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

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.That injured the artery when the surgeon removed the applier causing significant bleeding.Facing this urgency situation the surgeon used a smaller hemostasis forceps cat # 137081 + clip 001200 lot# 73j2000649 which caused a loss of signal from the recurrent nerve which controls voice function.Consequence: per-operative bleeding and possible recurrent nerve damage.This problem has occurred several times without consequence for patients.Each time we changed the applier and for this incident the applier had been changed 15 days before.Since this incident sales representative went on site on monday (b)(6) and changed appliers.The patient's condition is fine.The recurrent nerve is non-functional postoperatively.There were no underlying medical conditions.The reported clips and applier were confirmed.

Event Description

Incident happened on the (b)(6) 2021 in surgery room.During a thyroid surgery, the doctor had to use a blue titanium clip ref (b)(4); 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.That injured the artery when the surgeon removed the applier causing significant bleeding.Facing this urgency situation the surgeon used a smaller hemostasis forceps cat # 137081 + clip 001200 lot# 73j2000649 which caused a loss of signal from the recurrent nerve which controls voice function.Consequence: per-operative bleeding and possible recurrent nerve damage.This problem has occurred several times without consequence for patients.Each time we changed the applier and for this incident the applier had been changed 15 days before.Since this incident sales representative went on site on monday 08 november and changed appliers.The patient's condition is fine.The recurrent nerve is non-functional postoperatively.There were no underlying medical conditions.The reported clips and applier were confirmed.

Manufacturer Narrative

(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the tecomet inc.Kenosha wi facility as part of a (b)(4) piece lot in (b)(6) of 2019.Evaluation of the returned instrument shows that the tips are aligned in the open and closed position and the open tip gap measures to teleflex print specifications.Further evaluation shows that there is no damage to the jaws.Functional testing as performed at time of manufacture shows that this instrument is able to pick-up, retain, close and release multiple clips.Leg and eye gap measurement's measured within horizon medium clip specifications of.0060" max leg gap at(.0031-.0042") and.0073" max.Eye gap at (.0006-.0024".) we are unable to determine what caused the alleged defect at the end users facility since we are unable to find any non-conforming features on the returned device.All 100 instruments from this lot were 100% visually inspected and function tested at a 1.0 aql prior to shipment to the customer as this is a standardized procedure at this facility for this product line.Due to these findings, no further actions will be taken in response to this complaint and this record will be deemed closed.

• Brand Name: HZ APPLIER MED 8" CVD
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12836630
• MDR Text Key: 281215380
• Report Number: 3011137372-2021-00318
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 24026704710038
• UDI-Public: 24026704710038
• Combination Product (y/n): N
• Reporter Country Code: MN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• 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: 11/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN028188
• Device Catalogue Number: 237081
• Device Lot Number: 06K1757772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 27 KG