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

Model Number C650-129A

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

As reported, during a bladder biopsy and fulguration diagnostic procedure, the acmi monopolar cords (c650-129a) used with a bugbee electrode (acmi 257f8) caught fire during use.The incident occurred after brief intermittent use of instruments for several minutes.The cord was replaced with a different cord of the same kind.The intended procedure was completed with no harm or injury to the patient.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 10 years since the subject device was manufactured.Upon inspection, the complaint was confirmed.Based on the results of the investigation, the reported failure is likely due to the device being used beyond service life.This issue is addressed in the instructions for use (ifu): "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;" and "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." (cautions, page 1).Olympus will continue to monitor the field performance of this device.

Manufacturer Narrative

This report is being submitted to correct information previously reported.Field d4 / lot number has been corrected to identify lot number "bp" for the subject device of this report.

• Brand Name: MONOPOLAR ACTIVE CORD, BOVIE/VALLEYLAB GENERATORS
• Type of Device: MONOPOLAR ACTIVE CORD, BOVIE/VALLEYLAB GENERATORS
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 93 north pleasant st.; norwalk, OH 44857 ; 9013785969
• MDR Report Key: 12450747
• MDR Text Key: 270689297
• Report Number: 1519132-2021-00016
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 00821925008700
• UDI-Public: 00821925008700
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2022

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
• Device Operator: Health Professional
• Device Model Number: C650-129A
• Device Lot Number: BP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 10/28/2021; 02/09/2022
• Supplement Dates FDA Received: 11/02/2021; 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1952-2018
• Patient Sequence Number: 1
• Treatment: BUGBEE ELECTRODE (ACMI 257F8).; BUGBEE ELECTRODE (ACMI 257F8)