MAUDE Adverse Event Report: LUMENIS LTD VERSACUT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 0637-245-01

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2022

Event Type  Injury  

Event Description

It was reported that this morcellator stopped during a procedure due to a footswitch issue.The procedure was not completed.No patient complications were reported.This event is being reported for a cancelled/rescheduled procedure with a patient under anesthesia or sedation status unknown.

Event Description

It was reported that this morcellator stopped during a procedure due to an issue with the foot switch issue.The procedure was not completed.No patient complications were reported.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or whose sedation status was unknown.

Event Description

It was reported that this morcellator stopped during a procedure related with a foot switch issue.The procedure was not completed.No patient complications were reported.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or whose sedation status was unknown.

Manufacturer Narrative

Correction to h10: additional mfr narrative.The device is not available for analysis; however, the console was serviced by a field service engineer (fse) onsite.The case logs were reviewed, and the electrical safety test was performed which the laser console passed.The investigation shows there was no damage or malfunction related to the reported allegation.Based on the information available, the as reported footswitch issue that led to the procedure being cancelled was not confirmed.

• Brand Name: VERSACUT
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD; yokneam industrial park; hakidm; yokneam 20692 04; IS 2069204
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15825686
• MDR Text Key: 307177810
• Report Number: 2124215-2022-47806
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 07290109140681
• UDI-Public: 07290109140681
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0637-245-01
• Device Catalogue Number: 0637-245-01
• Device Lot Number: 0000001879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1