MAUDE Adverse Event Report: GYRUS ACMI, INC PK BUTTON (BOX OF 5); ELECTRODE, BUTTON

Model Number 786500

Device Problems Fire (1245); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

The referenced electrode was not returned to olympus for evaluation.The cause of the reported event could not be confirmed.However, based on similar reported events the potential cause of the reported event could be attributed to the electrode coming in contact with a metallic object or the settings on the generator are too high.The instruction manual provides warning which states, use extreme caution when using electrosurgery in close proximity to or in direct contact with any metal objects.The working channel and operating sheaths of most rigid endoscopes are metal.Do not activate the instrument while any portion of the instrument tip is within the working channel or in contact with another metal object.Localized heating of the instrument and the adjacent metal object or working channel may result in damage to the contacting endoscope, and/or instrument tip.In addition, the instruction manual of the 744000 generator provides caution which states, examine all accessories and connections to the electrosurgical generator before use.Improper connection may result in arcs and sparks, accessory malfunction, or unintended surgical effects.If additional information becomes available or if the electrode is returned at a later date, this report will be supplemented accordingly.

Event Description

Olympus was informed that during a procedure, the tip of the electrode sparked and caught fire inside the patient.The doctor tried a second unknown device and the exact same thing occurred.The doctor decided to stop using the generator and switched to a non-olympus generator to complete the procedure.There was no patient injury reported.

Manufacturer Narrative

On january 31, 2019, the user facility further reported that the reported event occurred during the middle of a transurethral resection of a prostate (turp) procedure when the charge nurse and surgeon reported that there was a spark observed inside the patient¿s prostate, but there was no flame or fire as originally reported.The procedure was terminated before there was any actual fire.The patient was inspected; no harm was observed to the patient.The surgeon switched to monopolar energy using a different non-olympus generator to complete the procedure.In addition, there was no device component that broke off and/or fell into the patient.There was no unexpected bleeding to the patient or delay in the procedure.There was no issue withdrawing the electrode from the patient.It was reported that the generator was set to default settings for the subject device.The subject device was inspected prior to procedure; no anomalies were noted.It is unknown if there was metal to metal contact.The reported device was discarded following the procedure.A dhr review was conducted and showed the concerned lot number was processed without any issues (ncrs or deviations) within the manufacturing process.A medical device report is being submitted for the second device that was confirmed to be an olympus electrode, model: 786500 (lot unknown).1 of 2 devices.

• Brand Name: PK BUTTON (BOX OF 5)
• Type of Device: ELECTRODE, BUTTON
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8215114
• MDR Text Key: 132208195
• Report Number: 2951238-2019-00322
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• PMA/PMN Number: K093181
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/06/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 786500
• Device Lot Number: U1803022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 01/31/2019
• Supplement Dates FDA Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ELECTRODE: OLYMPUS MD 786500, LOT UNKOWN; GENERATOR: OLYMPUS MO:744000, (B)(4)