MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE GRASPING FORCEPS(PARALLEL BASKET TYPE,3FR.); DISPOSABLE GRASPING FORCEPSBRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	FG-52D
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation and the investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
The customer reported to olympus, during a therapeutic percutaneous choledocholithiasis treatment on an unknown number of patients, the olympus device had difficulty collecting the bile duct stones.The customer reported there was an unknown number of procedures extended for five (5) hours due to this difficulty collecting the bile duct stones.The procedures were completed and no health hazards occurred.Attempts to gather more information are in progress.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information received from the customer.New information added to b5.
Event or Problem Description
Additional information received from the customer: the reported event involves one (1) patient.The physician reported when the fg-52d with three (3) wire basket is closed, the stones come off.This does not happen with the fg-52d four (4) wire basket.The procedure was successfully completed with the fg-52d.
Additional Manufacturer Narrative
Correction: b5.This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation, the device history records (dhr) review and applicable correction.New information added to the following fields: h6, h10.Since the device lot number was unknown, the dhr for the one year prior to the date of occurrence was inspected.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.The subject device was not returned to olympus, therefore the condition of the device could not be confirmed.Based on the available information, the legal manufacturer determined the reported event was not caused by a product defect.Fg-52d is a product with one less basket wire than fg-51d and consists of three basket wires.Due to product specifications, the distance between adjacent wires is larger.The calculus fell off between the wires while closing the basket.Olympus will continue to monitor the field performance of the device.
Event or Problem Description
The physician reported when the fg-52d with three (3) wire basket is closed, the stones come off.This does not happen with the fg-51d, which is composed of four (4) wires.

• Brand Name: DISPOSABLE GRASPING FORCEPS(PARALLEL BASKET TYPE,3FR.)
• Common Device Name: DISPOSABLE GRASPING FORCEPSBRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13588711
• Report Number: 8010047-2022-03470
• Device Sequence Number: 4019099
• Product Code: EOQ
• UDI-Device Identifier: 04953170375057
• UDI-Public: 04953170375057
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FG-52D
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 03/08/2022; 05/31/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 04/06/2022; 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown