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

Model Number 744000

Device Problem Unexpected Shutdown (4019)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

The unit was lost in transit to the service center; therefore, no evaluation could be performed.The cause of the reported event cannot be determined.However, a dhr review was performed for the complaint device serial number (b)(4) and no anomalies were noted with the manufacturing process that might explain the failure observed.

Event Description

The manufacturer was informed that during a therapeutic trans-urethral resection of the prostate (turp) procedure, the generator stopped working and resulted in unexpected severe bleeding.Coagulation was being performed when the unit stopped.The user facility reported that an unknown device was plugged into the generator.The generator settings were unknown.The bleeding was stopped using a monopolar device.The procedure was completed with that monopolar device.No longer stay or additional procedures needed.The procedure was prolonged by an hour.

Manufacturer Narrative

This supplemental report is being submitted to report additional information from the original equipment manufacturer (oem).As part of our investigation, the customer was contacted to provide further information on the devices used.When asked which electrode was used the response was ¿the usual¿ and ¿all possible¿ was the answer to which settings of the generator were used; it can therefore not be determined if the electrode was at fault and/or if the incorrect generator settings were used.The generator may produce an error if there is a fault in another part of the system e.G.The connector cable or the footswitch.Without any device to investigate and without a decipherable error code, it cannot be confirmed where the system has failed.The generator was manufactured in august 2011; it is out of the 12-month warranty period.There was no information provided about the calibration and maintenance of the generator.This generator was returned to the service centre in bolton in september 2018 where ¿problem with the footswitch¿ was reported and the root cause was determined ¿out of calibration¿.As per the maintenance and repair manual (b)(4) section 10.4, generators are to have a periodic review.The generator has not been sent to the service centre in bolton since september 2018; it is possible that the generator is out of calibration.Again, due to the device not being returned for investigation, this cannot be confirmed.In summary the root cause cannot be determined as the device has not been returned for investigation.The olympus iberia (oib) workshop service (mrs) have not provided any further details regarding the reported random error of ¿csec¿.It is possible that the error may be due to wear and tear of the generator due to the age of the device, however this cannot be confirmed.No other potential root causes could be identified due to the lack of information provided.

Manufacturer Narrative

A review has been performed over the last 2 years to determine if there have been any complaints reported for superpulse generators (744000), which have alleged a serious injury.There have not been any complaints for the 744000 that have reported a serious injury in this time period.The occurrence is classed as ¿occasional¿ in the ra, where it is likely to occur several times according to table c6.There has been one complaint for 744000 in the last two years that claims there was a problem with coagulation, however this complaint also states it was due to device blockage.

• 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
• MDR Report Key: 9653287
• MDR Text Key: 177841888
• Report Number: 2951238-2020-00329
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K031085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 744000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention