MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. GRASPING FORCEPS

Model Number	FG-301Q
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to the service center for evaluation.The customer did not provide a specific model/serial/lot number for the mentioned device; therefore the dhr, manufacturer and production records cannot be reviewed.The cause of the reported event cannot be determined.
Event or Problem Description
The service center was informed that during a diagnostic endoscopic retrograde cholangiopancreatography (ercp) procedure, the flower basket forceps became stuck in patient's anatomy.The doctor was attempting to remove a bile duct stone that was calcified when the phenomenon occurred.The doctor increased dilation and was able to remove the stone using the balloon.The basket was removed by pulling it out, no surgery needed.The procedure was completed with the same device and by dilation with a biliary balloon.There was no delay in procedure.There was no patient injury reported.

• Brand Name: GRASPING FORCEPS
• Common Device Name: GRASPING FORCEPS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9347406
• Report Number: 8010047-2019-04030
• Device Sequence Number: 2209717
• Product Code: OCZ
• UDI-Device Identifier: 04953170032479
• UDI-Public: 04953170032479
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K955063
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2019

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
• Operator of Device: Health Professional
• Device Model Number: FG-301Q
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1