MAUDE Adverse Event Report: GYRUS ACMI, INC. MONOPOLAR ACTIVE CORD, BOVIE/VALLEYLAB GENERATORS

Model Number	C650-129A
Medical Device Problem Codes	Disconnection (1171); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was manufactured in april 2008.The final manufacturing date is not available as the dhr did not include the packaging or labeling operations.The suspect device was sent to olympus for evaluation.The returned device was received with its connector detached.Burn marks were observed on the cable where the cord was damaged and severed.Microscope examination of the burned portion showed that the insulation had been slightly melted, and the wire had been charred.No kinks or cuts were found on the cable.The function test could not be performed because the cable was damaged.A review of the device history record found no deviations that could have caused or contributed to the reported event.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, the reported failure was most likely due to the device being used beyond its service life and/or the instruction for use (ifu) not being followed.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following cautions, which may help to prevent the issue: "when used as intended, this product is subject to wear or damage depending on the intensity of use.Inspect the product prior to each use to ensure it has no externally visible defects, including wear, kinks, cuts or pinching.Using this product when damaged may be hazardous." "this product has a restricted service life.Do not use the cable for a period of more than one year.Using the cable beyond one year may be hazardous." olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported there was a spark while using the subject device and it broke from the connection point.The customer was advised that the device was part of a recall and should not have been in use.Additional details were requested regarding the reported event.No additional information was provided.There was no harm or user injury reported due to the event.

• Brand Name: MONOPOLAR ACTIVE CORD, BOVIE/VALLEYLAB GENERATORS
• Common Device Name: MONOPOLAR ACTIVE CORD, BOVIE/VALLEYLAB GENERATORS
• Manufacturer (Section D): GYRUS ACMI, INC.; 93 north pleasant st; norwalk OH 44857
• Manufacturer Contact: todd brill ; 93 north pleasant st.; norwalk, OH 44857 ; 5082077661
• MDR Report Key: 15673615
• Report Number: 1519132-2022-00019
• Device Sequence Number: 6348102
• Product Code: FAS
• UDI-Device Identifier: 00821925008700
• UDI-Public: 00821925008700
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K890328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/26/2022

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: C650-129A
• Device Lot Number: DM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1952-2018
• Patient Sequence Number: 1
• Patient Sex: Unknown