FDA Adverse Event Malfunction Summary report: N

4.0MM VERSAPOINT RESECTING LOO

MDR report key: 10936689 · Received December 2, 2020

Report

Report Number: 2210968-2020-09522
Event Type: Malfunction
Date Received: December 2, 2020
Date of Event: November 4, 2019
Report Date: November 25, 2020
Manufacturer: ETHICON INC.
Product Code: HIH
PMA / PMN Number: K111751
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE ACTIVE TIP OF THE DEVICE HAS FRACTURED FROM THE DISTAL TIP. THE CONDITION OF THE FRACTURE FACE OF THE DEVICE SUGGESTS A BRITTLE FAILURE WITH NO OBVIOUS SIGNS OF MECHANICAL DAMAGE. INSTANCES OF SIMILAR FAILURES HAVE BEEN SEEN HISTORICALLY, WITH THE FAILURE LOCATION, MODE AND METHOD INDICATING FAILURE DUE TO SURFACE (HYDROGEN) EMBRITTLEMENT. THE REMAINDER OF THE ELECTRODE SHOW NO SIGNS OF DAMAGE. A CAPA WAS RAISED TO ADDRESS THE EVENT REPORTED. THE NECESSARY ACTIONS HAVE BEEN TAKEN TO ADDRESS THE ISSUE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH, AND NO NON-CONFORMANCES WERE IDENTIFIED. PRODUCT RELEASE DATE: JULY 2019. PRODUCT EXPIRE DATE: JUNE 2024. INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTEROSCOPY PROCEDURE ON (B)(6) 2019 AND AN ELECTRODE WAS USED. IT WAS REPORTED THAT THE RESECTION HANDLE BROKE DURING THE PROCEDURE AND IT WAS FOUND THAT THE ACTIVE TIP OF THE DEVICE HAD FRACTURED FROM THE DISTAL TIP. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1398165	4.0MM VERSAPOINT RESECTING LOO	COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR	HIH	ETHICON INC.		UGY1906104

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR