MAUDE Adverse Event Report: LAKE REGION MEDICAL 5FR GRASPER FORCEP; HYSTEROSCOPE (AND ACCESSORIES)

Model Number GYA-5

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported by the customer (and in mw5099333), during a loop electrical excision procedure (leep)/hysteroscopic polypectomy/removal of intrauterine device (iud) using a 5fr grasper forceps, the tip broke off during the procedure.The physician decided to use hysteroscopy graspers due to the iud being embedded in the myometrium upon visualization with the hysteroscopy.The grasper was introduced through the hysteroscope in the usual fashion and after 2-3 attempts to grasp the iud, the graspers upon withdrawal from the hysteroscope, were noted to have a device failure one side of the grasper was noted to be missing.There was no evidence of any retained instrument in the uterus; however, the small metal paddle part was never identified.A second pair of graspers were then introduced and used to dislodge the iud, which was delivered without difficulty.A full and thorough hysteroscopic evaluation of the uterine cavity was performed.There was no evidence of any retained instrumentation and a full survey was performed.The patient patient was copiously irrigated and all fluid was strained after the procedure.The patient has had no adverse effects as a result of this occurrence.

Manufacturer Narrative

This report is being updated to provide investigation findings.The original equipment manufacturer (oem) could not provide a device history record (dhr) or udi due to the device being manufactured in 2006, therefore, (dhr) for the complaint device could not be reviewed.The definitive cause of the reported issue could not be established.Olympus will continue to monitor complaints for this device through regular trending activities and take action if triggered by olympus qms procedure.

• Brand Name: 5FR GRASPER FORCEP
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): LAKE REGION MEDICAL; 45 lexington drive; laconia NH 03246
• MDR Report Key: 11360726
• MDR Text Key: 239691006
• Report Number: 3003790304-2021-00035
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• 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: 1552
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 86