MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE RETRIEVAL BASKET V

Model Number	FG-V432P
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device referenced in this report was not returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Event or Problem Description
We received the following report.During an endoscopic removal of a large stone (concretion), the subject device was used.The subject device could not be removed from the patient body.The user used the emergency lithotriptor, but the user could not remove the subject device since the basket wire was not broken off, but the operating wire was broken off at the proximal side.The patient was intubated until the following day and the stone was removed without further consequences.This is the report regarding the failure of the device's removal.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The broken wire was sent back for the evaluation.The length of the broken wire is 970mm.Ductile failure was found at the distal end of the operation wire.A pulling load was applied to the operation wire.That have caused the ductile failure.The outer diameter of the operation wire was measured.There was no abnormality found.The lot number of the subject device is unknown.As a result of checking the manufacturing record for past one year from the delivery date, it was found no irregularities.An excessive load beyond the strength limit was applied to the product when crushing an enlarged calculus by using the lithotripter.That might have caused the operation wire to break.The above device handling has warned in the instruction manual.

• Brand Name: SINGLE USE RETRIEVAL BASKET V
• Common Device Name: SINGLE USE RETRIEVAL BASKET
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10257222
• Report Number: 8010047-2020-04137
• Device Sequence Number: 14247686
• Product Code: OCZ
• UDI-Device Identifier: 04953170244063
• UDI-Public: 04953170244063
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K955063
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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: Other
• Device Model Number: FG-V432P
• Device Lot Number: .
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1