FDA Adverse Event Malfunction Summary report: N

VERSACUT TISSUE MORCELLATOR

MDR report key: 7159663 · Received January 3, 2018

Report

Report Number: 3004135191-2018-00005
Event Type: Malfunction
Date Received: January 3, 2018
Report Date: January 3, 2018
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

A LUMENIS SERVICE ENGINEER CONFIRMED THAT THE HANDPIECE "DID NOT WORK AT FIRST USE". ALTHOUGH NO INJURY WAS REPORTED AND NO MEDICAL INTERVENTION WAS REPORTED TO BE 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 AND MEDWATCH REPORT 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 "DIDN'T MOVE". 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
5795	VERSACUT TISSUE MORCELLATOR	SOFT TISSUE MORCELLATOR	GEI	LUMENIS LTD.	VERSACUT MORCELLATOR

Patients

Seq	Age	Sex	Outcome	Treatment
1