MAUDE Adverse Event Report: LAKE REGION MEDICAL FLEXIBLE GRASPING FORCEP; FLEXIBLE GRASPING FORCEPS

Model Number FA-558

Device Problem Break (1069)

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

Event Date 04/05/2022

Event Type  malfunction  

Manufacturer Narrative

The device is returned and an evaluation completed for it.The user¿s complaint was confirmed.Visual inspection of as received condition of the device confirmed that the jaw broke off; broken piece missing and not returned.The outer metallic coil was stretched out of shape, and the clear outer sheath covering the internal wires was scraped and torn.The remaining working length measures 26 cm (260 mm).Furthermore, the handle manipulation wire appears to be intact.However, when operating the handle, a restriction and noise would occur due to the damaged metallic coil.Due to physical damage, the device is not operational.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

As reported for this event by the customer, the device jaw broke.There is no reported harm to any patient.

Manufacturer Narrative

Additional information has been received from the customer.Correction being made to initial reporter first name.This supplemental report is being submitted to provide this information.Please see the updates in sections: b5, d5, e1, e2, e3, g2, g3, g6, h2, and h10.Patient information will not be provided by the customer.Devices used in conjunction with this device during the procedure are not known.

Event Description

Addendum (b)(6) 2022: event occurred in the beginning of a therapeutic ureteroscopy procedure.The procedure was completed with a new device of the same model number.There was a delay of approximately two to five minutes for replacement device to be brought into the room.The patient anesthesia was lengthened for those extra minutes.The device was inspected prior to use with no anomalies noted.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record (dhr), found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of this phenomenon could not be identified.The likely cause of the device's failure was user induced.The ifu states "to only apply a moderate amount of force.The resulting state of the device shows that this amount of force may have been exceeded." olympus will continue to monitor the field performance of this device.H4 updated october 2021.

• Brand Name: FLEXIBLE GRASPING FORCEP
• Type of Device: FLEXIBLE GRASPING FORCEPS
• Manufacturer (Section D): LAKE REGION MEDICAL; 45 lexington drive; laconia NH 03246
• Manufacturer Contact: brian motter ; 800 west park drive; westborough, MA 01581 ; 4848965250
• MDR Report Key: 14250512
• MDR Text Key: 290532490
• Report Number: 3003790304-2022-00065
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2022

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: FA-558
• Device Lot Number: 5145640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 04/29/2022
• Supplement Dates Manufacturer Received: 04/29/2022; 05/20/2022
• Supplement Dates FDA Received: 05/03/2022; 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1