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

Model Number C650-129A

Device Problems Disconnection (1171); Sparking (2595)

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

Event Date 07/16/2022

Event Type  malfunction  

Event Description

Olympus received a medwatch report via email on august 26, 2022.The medwatch report stated during a surgical procedure - cystoscopy with fulguration, a spark occurred at the junction of the bugbee electrical cord and the bugbee electrode.The male adapter on the bugbee cord became completely disconnect during the spark.There was no patient harm, no user injury reported due to the event.

Manufacturer Narrative

The subject device was not returned for evaluation.The medwatch sent to olympus does not include production lot and customer information.Additional information could not be obtained due to no customer information provided.Per device instructions for use (ifu) , this product shall not be used for a period of one year.Per the discontinuation notice of c650-129a , the product: c650-129a is discontinued and no longer available for sale by olympus, effective 18june2020.While, as reported, the event happened on (b)(6) 2022.So, it is likely that the subject device was used beyond its service life.Device history record (dhr) review could not be performed as lot number of the involved device was unknown.As lot number of the involved device was unknown, the manufacturing date is unknown.The ifu (rev: 99-0546_bf; 2021-01) states: "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 complaints for this device.

• Brand Name: MONOPOLAR ACTIVE CORD, BOVIE/VALLEYLAB GENERATORS
• Type of Device: 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: 15468766
• MDR Text Key: 306184786
• Report Number: 1519132-2022-00017
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 00821925008700
• UDI-Public: 00821925008700
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/22/2022

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1