MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY ULTRACLEAN 4 IN. BLADE 50/CASE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	139112
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 139112, ultraclean 4 in.Blade 50/case was being used on (b)(6) 2022 during a transforaminal lumbar interbody fusion, posterior spinal instrumentation fusion, bilateral sacroiliac joint fusion, and hardware removal and "when using product sku 139112 there was no visible indication of issue with device upon opening and using at beginning of case.Surgeon bent the electrode and it was after that surgeon realized the insulation breach where insulation meets plastic on electrode.Surgical team exchanged for another 139112 and surgeon was able to complete the procedure.Stray burn from insulation breach on electrode.Dressing applied in orderly fashion.¿ further assessment found that it is not believed that bending the electrode caused the device to break.The surgeon has been operating and using this technique without previous issue.Per surgeon, electrode was used with minimal bending.The burn was along the incision, and it is not known what degree of burn was received.The covidien force fx electrosurgical generator was used at 45 watts and will be listed as a concomitant device.There was no significant delay.There was no report of medical/surgical intervention.There was no extended stay for the patient.This report is being raised on the basis of injury due to unknown degree of burn.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 139112, ultraclean 4 in.Blade 50/case was being used on (b)(6)2022 during a transforaminal lumbar interbody fusion, posterior spinal instrumentation fusion, bilateral sacroiliac joint fusion, and hardware removal and "when using product sku 139112 there was no visible indication of issue with device upon opening and using at beginning of case.Surgeon bent the electrode and it was after that surgeon realized the insulation breach where insulation meets plastic on electrode.Surgical team exchanged for another 139112 and surgeon was able to complete the procedure.Stray burn from insulation breach on electrode.Dressing applied in orderly fashion.¿ further assessment found that it is not believed that bending the electrode caused the device to break.The surgeon has been operating and using this technique without previous issue.Per surgeon, electrode was used with minimal bending.The burn was along the incision, and it is not known what degree of burn was received.The covidien force fx electrosurgical generator was used at 45 watts and will be listed as a concomitant device.There was no significant delay.There was no report of medical/surgical intervention.There was no extended stay for the patient.This report is being raised on the basis of injury due to unknown degree of burn.
Additional Manufacturer Narrative
Received one 139112 in unoriginal package.Lot number was not verified.Performed a visual inspection, the insulation breach where insulation meets plastic on electrode was confirmed.Performed a functional inspection using the argon system 7750 (c8406), the device activated as intended; however, there were no obvious signs of arcing or indications of insulation exposure that would indicate the electrode caused a burn.Additionally, assessment of the event by engineering management determined that at no time would conmed advise bending of the product and bending of the product during use is considered misuse.Engineering management also indicated that the functional part of the product is the uncovered portion with the blue portion being insulation.Any break in the insulation in the blue or gray portion compromises the use of the product.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of two reports, regarding two devices, for this device family and failure mode.During this same time frame 3(b)(4)devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0000006.Per the instructions for use, the user is advised the following: an accessory holster may be used to hold active accessories safely.If using a disposable needle electrode, do not exceed 30 watts during use.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: ULTRACLEAN 4 IN. BLADE 50/CASE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 14742580
• Report Number: 3007305485-2022-00075
• Device Sequence Number: 14746534
• Product Code: GEI
• UDI-Device Identifier: 40653405007235
• UDI-Public: (01)40653405007235(17)251005(10)202010064
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K991855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/05/2025
• Device Model Number: 139112
• Device Catalogue Number: 139112
• Device Lot Number: 202010064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Unknown
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic