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U.S. Department of Health and Human Services

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

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GYRUS ACMI, INC GYRUS, PK-SP GENERATOR; ELECTROSURGICAL GENERATOR Back to Search Results
Model Number 744000
Device Problems Energy Output Problem (1431); No Device Output (1435)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported the device does not work and provided no further details, customer is checking the output and is not getting no output.The issue found during an unknown event.No harm was reported.No patient harm, no user injury reported due to the event.
 
Manufacturer Narrative
Technical assistance center (tac) support engineer communication with the customer (biomed) instructed on how to review the error log.The error log was found with no listed errors in the log.Tac provided troubleshooting with the customer and in addition, provided the pk superpulse biomed service manual.Tac instructed customer to perform an out put check with the following cables: test cable 560084-001 and connector cable 39000.In a follow up communication, the customer reported that they were able to perform a successful functional check on the unit and have returned it to service.Tac noted the "output check passed, device was put back into use".The subject device was not returned to olympus, it is unknown at this time what have caused the reported issue.Investigation is ongoing.This report will be supplemented accordingly following investigation.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the service history record found no deviations that could have caused or contributed to the reported phenomenon.The issues reported in this complaint are likely not from the repair of this device.Based on the results of the investigation, it was noted that the customer was not testing the unit's output properly.Olympus will continue to monitor field performance for this device.
 
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Brand Name
GYRUS, PK-SP GENERATOR
Type of Device
ELECTROSURGICAL GENERATOR
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 Key15961411
MDR Text Key307820866
Report Number3003790304-2022-00330
Device Sequence Number1
Product Code GEI
UDI-Device Identifier00821925009271
UDI-Public00821925009271
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031085
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/08/2023
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 Number744000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/14/2022
Initial Date FDA Received12/12/2022
Supplement Dates Manufacturer Received02/13/2023
Supplement Dates FDA Received03/08/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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