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

Model Number 920005PK

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The user¿s complaint was not confirmed.No findings available.The cause could not be determined.No further information was reported.A supplemental will be submitted if new information becomes available or the device is returned.

Event Description

The user facility reported that a part of the device broke during a therapeutic laparoscopic hysterectomy procedure.The cutting button on the side of the device broke off.The procedure was completed with the same device.There was no patient injury reported.No additional information was provided.

Event Description

Please see h10.

Manufacturer Narrative

Upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: PKS CUT/FCP, 5MM/33CM 9-PIN (5/PK)
• Type of Device: CUTTING AND COAGULATION ACCESSORY
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10438020
• MDR Text Key: 216921314
• Report Number: 3011050570-2020-00050
• Device Sequence Number: 1
• Product Code: NUJ
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• 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: FR886076
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1