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

Model Number FG-V451P

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

Only the wire assembly of the subject device was returned to olympus medical systems corp.(omsc) for evaluation.The coil sheath, operating part, or operating pipe were not returned.The operation pipe was broken near the base of the operation part.The fracture surface showed that a large load was applied.The basket wire was deformed.The loop member of the center wire was broken.The fracture surface showed that a large load was applied.The manufacturing record was reviewed and found no irregularities.Based on the investigation results, omsc presumes that the breakage of the center wire was caused since a large load more than the durability of the subject device was applied to the center wire during crushing.The above device handling has warned in the instruction manual.

Event Description

During a procedure, the subject device was used.The basket of the subject device could not be opened.The intended procedure was completed with another device.There was no patient injury reported.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc found that the basket wire was damaged, the operation pipe was broken off, and the center wire was broken off.On november 16, 2020, omsc judged that the breakage of the center wire was reportable event.This is the report regarding the breakage of the center wire.

• Brand Name: SINGLE USE RETRIEVAL NITINOL BASKET V
• Type of Device: SINGLE USE RETRIEVAL BASKET
• 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: 10947512
• MDR Text Key: 226717667
• Report Number: 8010047-2020-09829
• Device Sequence Number: 1
• Product Code: LQR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170811
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FG-V451P
• Device Lot Number: 9ZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1