MAUDE Adverse Event Report: GYRUS ACMI, INC PKS CUT/FCP, 5MM/33CM 9-PIN (5/PK); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 920005PK

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

This is the first of two associated medwatch reports filed for this event.Two failed devices were used in the event, and the procedure was successfully completed with a third.Additional information is not yet available for this event.The device is returned, but the device evaluation is not yet completed.As such, a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.

Event Description

As reported for this event, during an unknown therapeutic procedure, when the doctor was using the device there was no output.This happened to another device used after this one, and the procedure was completed using a third device.There was harm, or adverse impact to the patient.

Manufacturer Narrative

A used cutting forceps ref.(b)(4), lot# fr946636, was returned for evaluation due to no output after a few minutes.The device was received with the jaws open, lock on.A visual inspection indicates that there are dried tissues on jaw consistent with use.The jaw symmetry is not balanced, and slightly bent, possibly due to grasping tissue with excessive force during use, but it is still functional.The jaw is also not fully wide open; the jaw aperture measurement was taken inside the first teeth of the jaw, measured at.175" (standard is.300¿ +/-.100¿).The jaw mesh is not aligned.The insulation of the jaw legs was inspected and found jaw leg insulation with crack exposing the electrode beneath, however the flare is normal.The blade was tested multiple times, and did cut the dental dam without a problem.The lock function works as designed and the shaft is straight.The blade extends and retracts as designed.Noted that the cord of the device was cut by user, and not returned.Due to the damaged cord, the device could not be tested for functionality.Therefore, the reported complaint was not confirmed.Device history record was reviewed and showed the product met all specifications upon release.Per the instructions for use: "if forcep jaws come in contact with each other when the power is activated, the instrument will short out.Simply release the jaws so they are not in contact with each other and the forceps will become operational".The user most likely experienced the defect due to insulation failure in jaws, and the jaws being slightly bent most likely due to excessive force.Olympus will continue to monitor the field performance of this device.

• Brand Name: PKS CUT/FCP, 5MM/33CM 9-PIN (5/PK)
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10731375
• MDR Text Key: 214172642
• Report Number: 3011050570-2020-00127
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K023492
• 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: 01/28/2021

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: 920005PK
• Device Lot Number: FR946636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1