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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LUMENIS LTD VERSACUT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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LUMENIS LTD VERSACUT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 0636-454-01
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2023
Event Type  malfunction  
Event Description
It was reported that during a holmium laser enucleation of the prostate (holep) procedure a fragment of the versacut blade broke off inside the patient.The fragments were completely recovered from the patient.The procedure was completed with this device without patient complications.
 
Event Description
It was reported that during a holmium laser enucleation of the prostate (holep) procedure a fragment of the versacut blade broke off inside the patient.The fragments were completely recovered from the patient.The procedure was completed with this device without patient complications.
 
Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis identified that the device was returned with the inner cutting piece in the unit.Outer and inner pieces straight with no kinks and no issues.The outer piece cutting window was broken and missing top part.Outer and inner piece connector were in good physical condition; no work order was assigned to this case.It is likely that the versacut blade was damaged, therefore, the reported allegation is confirmed.The component damaged could have affected the device performance and its integrity leading to the event experienced by the customer.According to the device instructions for use (ifu), there is no objective evidence that indicates user did not properly handle / use device, the complaint is not against the ifu.Since an expected or random component failure was identified without any design or manufacturing issue, the conclusion code of cause traced to component failure is selected for the complaint.
 
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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.
hakidma st 6
yokneam 20692 04
IS   2069204
Manufacturer Contact
john stoffregen
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key16577524
MDR Text Key311681684
Report Number2124215-2023-12438
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0636-454-01
Device Catalogue Number0636-454-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received06/30/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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