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

Model Number	0637-245-01
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2124215-2022-47806
• Device Sequence Number: 6156850
• Product Code: GCJ
• UDI-Device Identifier: 07290109140681
• UDI-Public: 07290109140681
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 11/24/2022; 02/09/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 12/09/2022; 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown