MAUDE Adverse Event Report: GYRUS ACMI, INC. GYRUS, PK-SP GENERATOR; ELECTROSURGICAL UNIT

Model Number 744000

Device Problem No Device Output (1435)

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

Event Date 07/29/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The exact cause of the reported phenomenon could not be determined at this time.If the device is received or new information becomes available later, this report will be supplemented.

Event Description

It was reported that there was no output on the generator, not cutting continuously and band was skipping across the tissue.The generator intermittently failed during maintenance.There was no patient or user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.A review of the service history record found no deviations that could have caused or contributed to the reported issue.The device was returned and evaluated.The evaluation identified a missing d socket cove, scratches and some puncture holes on the keypad, snaps holding boards were broken, and confirmed the cutting failure.Additionally, it was found that there was an error code 400.The code is generated an electrode from the transurethral resection in saline (turis) system is attached and activated without a saline solution being present or there is an electrode connection fault.The likely root cause of the cutting failure was a broken core of the transformer on the printed circuit board.The unit was repaired and passed all functional tests.Olympus will continue to monitor field performance for this device.

• Brand Name: GYRUS, PK-SP GENERATOR
• Type of Device: ELECTROSURGICAL UNIT
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15299234
• MDR Text Key: 302848771
• Report Number: 3003790304-2022-00172
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925009271
• UDI-Public: 00821925009271
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 744000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2005
• 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