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

Catalog Number	137081
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
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 "the clip could not be loaded to the applier firmly and it almost fell off during a surgery.(it did not actually fall off.) therefore, the applier was replaced with a new one to complete the procedure.No clip fell/remained in the patient, and no injury to the patient occurred.The applier was sent to our technical specialist, who confirmed the jaws were misaligned.The applier was purchased by the hospital on (b)(6) 2023 and it was the first time to use".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The sample was returned for investigation.The manufacturer reported: "the dhr for the returned instrument was reviewed and found complete without any irregularities.This instrument was produced at the tecomet, inc.Kenosha wi facility as part of a (b)(4) pc.Lot in april of 2023.It was found that this order was made from the correct materials and components and all approved processes were followed.It can then be stated that the alleged non-conformance inciting this complaint was not due to an error in tecomet -kenosha's manufacturing process.Evaluation of the returned instrument shows that the jaws are slightly misaligned in the closed position.Functional evaluation of this instrument shows that although the jaws are slightly misaligned in the closed position it was still able to pick-up, retain, close and release multiple clips without any issues found.We are able to validate this complaint for the returned instrument.We are unable to determine what caused the jaws to become misaligned but mishandling of this device at the end user's facility during cleaning and sterilization processing is suspected."all (b)(4) instruments from this lot were 100% visually inspected and function tested 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." teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that "the clip could not be loaded to the applier firmly and it almost fell off during a surgery.(it did not actually fall off.) therefore, the applier was replaced with a new one to complete the procedure.No clip fell/remained in the patient, and no injury to the patient occurred.The applier was sent to our technical specialist, who confirmed the jaws were misaligned.The applier was purchased by the hospital on (b)(6) 2023 and it was the first time to use".No patient harm or injury.The patient status is reported as "fine".

• Brand Name: HZ APPLIER SMALL 8" CVD
• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18583013
• Report Number: 3011137372-2024-00019
• Device Sequence Number: 8203082
• Product Code: GDO
• UDI-Device Identifier: 34026704622611
• UDI-Public: 34026704622611
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2024

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: 137081
• Device Lot Number: 06J2254495
• 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: Not provided
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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