MAUDE Adverse Event Report: GYRUS ACMI, INC. GYRUS, PK-SP GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 744000

Device Problem Break (1069)

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

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned and the evaluation found no malfunctions aside from the allegation reported in b5.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed that during the device evaluation, the generator exhibited that the left side core of the printed circuit board was broken.There was no patient involved.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to field b5, h3, h4 and h6.The allegation was confirmed due to a burnt loom on the circuit board and the left side of core of circuit board was broken.A dhr review was not performed as this device has been serviced before/serviced multiple times.A review of the previous service was performed.The previous service had no abnormalities noted that could have attributed to the failures in this complaint.Because of this it is likely that the issues reported in this complaint were not from the service of this device a definitive root cause is unable to be determined for this complaint.The display error was due to the circuit board being broken.The root cause of the pkrf board breaking cannot be determined but may have been due to dropping the device, olympus will continue to monitor field performance for this device.

Event Description

The customer reported that during preparation for a bipolar transurethral resection of the prostate (turp) procedure, the generator did not work when plugged in and the display was not working.The intended procedure was completed with a similar device without delay.The patient was not under anesthesia.There was no impact on a patient.

• Brand Name: GYRUS, PK-SP GENERATOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18924073
• MDR Text Key: 337904890
• Report Number: 3011050570-2024-00105
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

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: Other
• Device Model Number: 744000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2007
• 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