FDA Adverse Event Malfunction Summary report: N

HOL ML 5MM ENDO APPLIER

MDR report key: 10993407 · Received December 11, 2020

Report

Report Number: 3011137372-2020-00277
Event Type: Malfunction
Date Received: December 11, 2020
Date of Event: September 17, 2020
Report Date: November 27, 2020
Manufacturer: TELEFLEX MEDICAL
Product Code: GDO
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TH
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

(B)(4). PER CUSTOMER PROVIDED INFORMATION THE DHR FOR THE ALLEGED INSTRUMENT WAS REVIEWED AND FOUND COMPLETE WITHOUT ANY IRREGULARITIES. THE ALLEGED INSTRUMENT WAS PRODUCED AT THE TECOMET, INC. KENOSHA WI FACILITY AS PART OF A (B)(4) PC. LOT IN JUNE OF 2019. THIS INSTRUMENT HAS NOT BEEN RETURNED FOR REVIEW OR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE ALLEGED DEFECT OR VALIDATE THE ALLEGED COMPLAINT. PER LOT INFORMATION PROVIDED ALL 50 INSTRUMENTS FROM THE ALLEGED INSTRUMENTS 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.

Description of Event or Problem · 0

ISSUE REPORTED: AFTER LOAD HOL WITH CLIP INTO THE ACCESS PORT BUT APPLIER CANNOT LOCK THE VESSEL. DOCTOR TRIED TO LOCK MANY TIMES BUT CANNOT CLIP THEN HE BRINGS APPLIER OUT AND CHANGE NEW ONE.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

Description of Event or Problem · 1

ISSUE REPORTED: AFTER LOAD HOL WITH CLIP INTO THE ACCESS PORT BUT APPLIER CANNOT LOCK THE VESSEL. DOCTOR TRIED TO LOCK MANY TIMES BUT CANNOT CLIP THEN HE BRINGS APPLIER OUT AND CHANGE NEW ONE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1456793	HOL ML 5MM ENDO APPLIER	APPLIER, SURGICAL, CLIP	GDO	TELEFLEX MEDICAL		06F1871334

Patients

Seq	Age	Sex	Outcome	Treatment
1