MAUDE Adverse Event Report: LAKE REGION MEDICAL 5FR GRASPER FORCEP

Model Number GYA-5

Device Problems Break (1069); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during an unspecified procedure, the user was using the grasper gya-5 and the pieces from the device jaw broke off and fell into the patient.According to the reporter, the facility or (operating room) team removed the broken pieces from the patient.The patient underwent an x-ray to find out if everything (all the pieces) that fell were removed.No further details were provided regarding the event.No patient harm or injury reported due to the event.No user injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide trend analysis and investigation conclusion.Physical evaluation of the device cannot be performed as the customer is not returning device and no pictures have been provided.A dhr review could not be performed on this device because the serial number is unknown.The root cause of the reported issue was not identified.Olympus will continue to monitor complaints for this device.

• Brand Name: 5FR GRASPER FORCEP
• Type of Device: 5FR GRASPER FORCEP
• Manufacturer (Section D): LAKE REGION MEDICAL; 45 lexington drive; laconia NH 03246
• MDR Report Key: 10605892
• MDR Text Key: 209168893
• Report Number: 3003790304-2020-00094
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT-HIH
• 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: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GYA-5
• Device Lot Number: N/A
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1