MAUDE Adverse Event Report: MISONIX INC BONESCALPEL ULTRSONIC SURGICAL ASPIRATION SYSTEM GENERATOR; ULTRASONIC SURGICAL SYSTEM

Model Number BCM-GN

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

Customer/user did not return all associative devices to test system.Awaiting the return of additional item in order to perform evaluation.Follow-up report to be filed at a later date.

Event Description

Customer stated problem as, "this machine has been in hospital to be checked before using with patients.They found out that there is electricity leak from the machine 5406ua (they accept max 5000ua).We are not able to use this machine with patients.This machine has not been used on that hospital with patients treatments.There has been only demonstration for the staff".

Manufacturer Narrative

Follow-up #1 complaint (add number) is associated with rma # (b)(4) which was issued due to a leakage current measurement above the customers specification of 5000ua.Multiple devices, including two (2) bonescalpel handpieces, serial #(b)(4) and serial #(b)(4), a bonescalpel footswitch serial #(b)(4) and a bonescalpel generator bc-1241-2016 were returned under the rma.The generator and footswitch were evaluated by the service department on 12/05/2018 as work order # (b)(4).Bonescalpel handpieces, serial #(b)(4) was evaluated on 12/05/2018] and serial #(b)(4) was evaluated on 12/27/2018].The customer stated, "this machine has been in hospital to be checked before using with patients.They found out that there is electricity leak from the machine 5406ua (they accept max 5000ua).We are not able to use this machine with patients.This machine has not been used on that hospital with patients treatments.There has been only demonstration for the staff." customer provided documentation for tests performed, as noted in the problem statement.The generator is owned by misonix' distributor (b)(4) and was being used to demonstrate the bonescalpel to a hospital in (b)(6).The device was being tested by the hospital biomed team prior to the demonstration as per their procedures.Upon receipt of the generator at misonix, the unit passed the initial visual inspection.The generator was evaluated with the returned handpiece 5255-17-01, and found to meet all specifications/no problem found using procedures sm-801 appendix b - test and calibration data sheet, (b)(4) - bonescalpel and sonicone or hp test data and stm-09-04 - safety test final inspection.An electrical fault was not detected during testing.The second handpiece, serial # (b)(4) was received at misonix and evaluated on 12/27/2018, and found to meet all specifications/no problem found using procedures (b)(4) - bonescalpel and sonicone or hp test data and stm-09-04 - safety test final inspection.The customer stated the generator failed "direct patient leakage current" electrical test with a reading of 5406ua (customers limit is <5000ua).Internally misonix tests for patient leakage with the ground connected (limit is <100ua for type b device per iec60601-1) and also with the ground open (limit is <500ua type b device per iec 60601-1).The customers "patient leakage" limit of 5000ua is 10x greater than the standard.Their recorded value of 5406ua would have caused the patient leakage safety circuit in the generator to trip, however the customer did not mention the generator producing any faults.Additionally, the misonix repair department did not observe any faults.The results reported above were from tests performed on the system using a misonix power cord with a us male plug at eeu mains voltage of 220v.The test equipment does not have an eeu ((b)(6)) female receptacle.The customer eeu power cord with and eeu male plug was tested separately for continuity and failed.The ground of the plug was registering 40vac coming from line one (1) and readings were erratic.The possible root cause of the customer's observation of a high leakage current was due to an inadequate ground connection in the power cord.The root cause of the inadequate ground connection in the power cord could not be determined.The generator, along with the associated footswitch and handpieces are being returned to the customer.We have also indicated that the cord should be tested and potentially taken out of service by the customer.Misonix inc.Performed a trend analysis from january 2017 to january 2019 for leakage current and power cord issues.This is the first complaint for leakage current or power cord issues we received.(b)(4).

Event Description

Customer stated problem as, "this machine has been in hospital to be checked before using with patients.They found out that there is electricity leak from the machine 5406ua ( they accept max 5000ua).We are not able to use this machine with patients.This machine has not been used on that hospital with patients treatments.There has been only demonstration for the staff.".

• Brand Name: BONESCALPEL ULTRSONIC SURGICAL ASPIRATION SYSTEM GENERATOR
• Type of Device: ULTRASONIC SURGICAL SYSTEM
• Manufacturer (Section D): MISONIX INC; 1938 new highway; farmingdale NY 11735
• MDR Report Key: 8186908
• MDR Text Key: 131489845
• Report Number: 2435119-2018-00016
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 00841626100664
• UDI-Public: 00841626100664
• Combination Product (y/n): N
• PMA/PMN Number: K070313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: BCM-GN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Date Manufacturer Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1