MAUDE Adverse Event Report: LAKE REGION MEDICAL 5FR GRASPER FORCEP; LAPAROSCOPIC GRASPING FORCEPS

Model Number GYA-5

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2021

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 during a hysteroscopy using a 5fr grasper forceps, one side of the dislodged and was inside the patient.At the time of the report, the physician was in the process of removing the device fragment from the patient.There was no reported impact to the patient as a result of this occurrence.Multiple attempts to gather additional details regarding the patient/event have been made with no response from the customer.

Event Description

The issue occurred in the middle of a therapeutic procedure to remove an embedded intrauterine device (iud).The reported issue caused a >30 minute delay in the procedure.The procedure was completed with another unspecified device.The device is not available for return to olympus.There was no perforation, hemorrhage, or mucous membrane damage due to this occurrence.The jaw piece that dislodge was not removed found/removed from the patient, but it was present on x-ray.The physician stated the patient may need future x-ray and piece removal with repeat hysteroscopy.The device was inspected before use and no abnormalities were noted.

Manufacturer Narrative

This report is being submitted to report additional information provided by the customer.New information is reported in a2, a3, a4, b5, d4 (lot number), and d10.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The following sections were updated: d8, g3, g6, h2, h6, h10.Three unsuccessful attempts to retrieve a device history record (dhr), unique device identifier and manufacturing date have been made.Since there was no physical device evaluation and no dhr, a definitive root cause could not be determined.However, it is likely the jaw was dislodged due to the use of excessive force.

• Brand Name: 5FR GRASPER FORCEP
• Type of Device: LAPAROSCOPIC GRASPING FORCEPS
• Manufacturer (Section D): LAKE REGION MEDICAL; 45 lexington drive; laconia NH 03246
• MDR Report Key: 11596631
• MDR Text Key: 260779053
• Report Number: 3003790304-2021-00060
• 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: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2021

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: GYA-5
• Device Lot Number: 2238MT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 04/07/2021; 05/05/2021
• Supplement Dates FDA Received: 04/30/2021; 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5.5FR SHEATH, LOT 151W-017, AND A4674A-SN (B)(6).
• Patient Age: 58 YR
• Patient Weight: 89