FDA Adverse Event Malfunction Summary report: N

VERSACUT TISSUE MORCELLATOR

MDR report key: 7112438 · Received December 13, 2017

Report

Report Number: 3004135191-2017-00234
Event Type: Malfunction
Date Received: December 13, 2017
Report Date: December 13, 2017
Manufacturer: LUMENIS LTD.
Product Code: GEI
PMA / PMN Number: K050639
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: SERVICE PERSONNEL

Narratives

Additional Manufacturer Narrative · 1

ALTHOUGH NO INJURY WAS REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT, LUMENIS IS AWARE THAT THE SAME MALFUNCTION WAS ALLEGED TO HAVE CAUSED OR CONTINUED TO A 'SERIOUS INJURY' (CANCELLED PROCEDURE OF AN ANESTHETIZED PATIENT : MDR# 3004135191-2017-00186). LUMENIS IS REPORTING THIS EVENT AS IT REPRESENTS A REPORTABLE MALFUNCTION. LUMENIS HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; THE COMPLAINT FILE WILL BE UPDATED ACCORDINGLY LUMENIS INITIATED CAPA #(B)(4) TO CONTINUE ITS INVESTIGATION OF THIS AND SIMILAR REPORTED EVENTS, AND TO DETERMINE CORRECTIVE ACTION.

Description of Event or Problem · 1

A FOREIGN USER FACILITY REPORTED THAT THEIR LUMENIS VERSACUT TISSUE MORCELLATOR'S "BLADES WERE NOT MOVING" DURING A PROCEDURE. NO REPORT OF PATIENT INJURY OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. LUMENIS HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; THE COMPLAINT FILE AND MDR WILL BE UPDATED ACCORDINGLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
893131	VERSACUT TISSUE MORCELLATOR	SOFT TISSUE MORCELLATOR	GEI	LUMENIS LTD.	VERSACUT MORCELLATOR

Patients

Seq	Age	Sex	Outcome	Treatment
1