MAUDE Adverse Event Report: LAKE REGION MEDICAL FLEXIBLE GRASPING FORCEP

Model Number FA-558

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The exact cause of the reported event cannot be determined.The fa-558 flexible grasping forcep instruction manual warns users ¿do not use an instrument that fails to meet the criteria stated in the labeling or that has been damaged.Keep instruments separate from one another to avoid damage.To ensure satisfactory performance, perform the prescribed inspections and operational tests as recommended.¿.

Event Description

Olympus was informed that during a stent removal procedure; the forceps broke and fell apart, while the surgeon was attempting to remove a stent.No device fragment fell into the patient.The broken fragment was retrieved from the sterile field.There was no bleeding reported.The intended procedure was completed.Additionally, the device was inspected prior to the procedure with no anomalies found.

Manufacturer Narrative

This supplemental report is being submitted to provide the device investigation findings and to update.The device was investigated at the original equipment manufacturer (oem).The oem investigation confirmed the reported device issue.The device showed evidence of being over-actuated.The finger rings were pulled passed their intended stopping point.It was also noted that the actuation wire was pulled and severely bent.There were no identified defects found related to the manufacturing and assembly of the reported device.The damage found during the device investigation was likely caused by excessive force being applied to the device during actuation.

• Brand Name: FLEXIBLE GRASPING FORCEP
• Type of Device: FLEXIBLE GRASPING FORCEP
• Manufacturer (Section D): LAKE REGION MEDICAL; 45 lexington drive; laconia NH 03246
• MDR Report Key: 7301164
• MDR Text Key: 101504707
• Report Number: 2951238-2018-00134
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

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 Catalogue Number: FA-558
• Device Lot Number: G41175
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/27/2018
• Supplement Dates Manufacturer Received: 03/20/2018
• Supplement Dates FDA Received: 04/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1