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

Model Number 744000

Device Problem No Device Output (1435)

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

Event Date 04/28/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Customer reported with an issue of "left side no output after getting back from repairs".Per the report, the issue was found upon return of product from vendor repair , stated "no patient was presented to the equipment.Out of box failure ".No patient involvement , no procedure involved on this reported event.No user injury reported.

Manufacturer Narrative

Complaint reported no output from the left side of the generator.It was recommended that the customer send the device back for warranty repair.The subject device was received and evaluated.Upon inspection when the device was returned, it was confirmed that there was an output issue with the generator.Additionally, the fuse drawer was damaged and the left side of the pulse kinetic (pk ) output loom was not functioning as intended.This was an out of box failure and was not used during any procedure.A device history record (dhr) review will not be performed as this device has been serviced before by olympus therefore a service history review will replace dhr review.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.It is likely that the issues reported in this complaint were not from the service of this device.The root cause was unable to be determined; however, a possible explanation for the issue reported could have been from damage to unit during shipping.Olympus will continue to monitor complaints for this device.Supplemental report(s) will be submitted should any relevant new information is available and or received.

• Brand Name: GYRUS, PK-SP GENERATOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): 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: 16990242
• MDR Text Key: 315827575
• Report Number: 3003790304-2023-00198
• 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: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• 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
• Date Returned to Manufacturer: 05/01/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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