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

Model Number 786500

Device Problem Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

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.First device report was submitted on mfr# 2951238-2019-00322.

Event Description

Olympus was informed that during the middle of a transurethral resection of a prostate (turp) procedure, the charge nurse and surgeon reported that there was a spark observed inside the patient¿s prostate.The surgeon used a second similar device and the exact same thing occurred.The procedure was stopped before there was any actual fire.The patient was inspected; no harm was observed to the patient.The surgeon decided to stop using the generator and switched to monopolar energy using a different non-olympus generator to complete the procedure.In addition, no device component 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.The generator was set to default settings for the pk button.The reported device was inspected prior to procedure with no anomalies observed.It is unknown if there was metal to metal contact.The reported device was discarded following the procedure.2 of 2.

• Brand Name: PK BUTTON (BOX OF 5)
• Type of Device: ELECTRODE, BUTTON
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8313594
• MDR Text Key: 137731679
• Report Number: 2951238-2019-00425
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093181
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 786500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1