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

Model Number GYA-5

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to returned to the service center for evaluation.Olympus followed up with the user facility regarding the reported event and was informed no additional information was available.The exact cause of the reported event cannot be determined at this time; however, based on similar reports, the most probable cause of the reported event can be attributed to user handling due to excessive force applied to the device in the field.The instruction manual provides an operational test to be performed by the user prior to each use."visually examine the instrument to confirm it is free of any rough edges, burrs, and irregularities.Using the handle and finger grip, open and close the forceps a few times to verify that the forceps operate smoothly.Always operate the forceps lightly-excessive force on the finger grip (either pushing or pulling) can cause deterioration and breakage.".

Event Description

The service center was informed that during an unspecified procedure, the lower jaw of the forceps broke off and fell into the patient.The intended procedure was completed.There was no patient injury reported.

• Brand Name: 5FR GRASPER FORCEP
• Type of Device: 5FR GRASPER FORCEP
• Manufacturer (Section D): LAKE REGION MEDICAL; 45 lexington drive; laconia NH 03246
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 9315321
• MDR Text Key: 204564091
• Report Number: 2951238-2019-01185
• Device Sequence Number: 1
• Product Code: HIH
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GYA-5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1