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

Model Number 744000

Device Problem Output below Specifications (3004)

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

Event Date 09/02/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

As reported, the okm¿s (keymed) fse (field service engineer) attended a customer call out in relation to their 744000 pk superpulse generator, sn (b)(4) with a customer specified fault of " the device does not meet limits for sp2 and sp1 ¿ 200w - 330 , 1000.The values are under limits.During the fse engineer¿s investigation, the reported fault was confirmed and was identified to be linked to a faulty sprf board/pulse.There is no patient involvement associated on this reported event.No user injury reported.Prior to this reported event the subject device was used on a (transurethral resection of the prostate) procedure, however, the device was not used to complete the procedure.Another similar device was used to complete the procedure with no patient harm or injury reported.This report is related to a report with patient identifier (b)(6).

Manufacturer Narrative

This supplemental report is to inform that upon further review, this is not a reportable malfunction.This report was found to be a duplicate of patient identifier c21335640.

• Brand Name: GYRUS, PK-SP GENERATOR
• Type of Device: GYRUS, PK-SP GENERATOR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 118 turnpike road; southborough, MA 01772 ; 9013785969
• MDR Report Key: 12558801
• MDR Text Key: 274581789
• Report Number: 3003790304-2021-00149
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K031085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 09/30/2021
• Supplement Dates Manufacturer Received: 11/25/2021
• Supplement Dates FDA Received: 05/19/2022
• 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