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

Model Number 744000

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 06/02/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device is not being returned to olympus for evaluation.The investigation is ongoing; therefore, a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported that error message- check irrigation/ electrode (error 400 ref 26) was displayed during an unspecified procedure.There was no patient or user injury reported due to the event.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.

Manufacturer Narrative

The device was returned to olympus for inspection, and the customer's complaint was not confirmed.Additionally, the repair center found minor scratches on the housing, missing mounting foot, and a missing d socket cover.Additionally, the fault log showed error code 400 ref 26.(this error can occur if a turis electrode is attached and activate without a saline solution being present, or there is an electrode connection fault.) a review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, the root cause of the error code 400 ref 26 was unable to be identified.Olympus will continue to monitor field performance for this device.

Event Description

Additional information was received from the customer which confirmed that the procedure was completed using the subject device.There was no patient harm or consequence reported as a result of the event.

• Brand Name: GYRUS, PK-SP GENERATOR
• Type of Device: ELECTROSURGICAL SYSTEM
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: brian motter ; 800 west park drive; westborough, MA 01581 ; 4848965250
• MDR Report Key: 14891079
• MDR Text Key: 302926070
• Report Number: 3003790304-2022-00110
• 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: 10/07/2022

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: 744000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/03/2022
• Initial Date FDA Received: 07/01/2022
• Supplement Dates Manufacturer Received: 07/18/2022
• Supplement Dates FDA Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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