MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE MECHANICAL LITHOTRIPTOR V

Model Number BML-V237QR-30

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The sheath¿s knob was turned counterclockwise and leaned.The coil sheath could not be slid.The knob bit in the groove and the groove was deformed.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that the coil sheath could not be slid since the knob was turned counterclockwise too much, and the knob bit the slider part.As a result, the subject device was incarcerated.The instruction manual of the device has already warned as follows; sliding of the coil sheath can be fixed by turning the knob clockwise until it stops.It slides again by turning the knob counterclockwise about 90°from that position and then released.If you turn the knob counterclockwise again until it stops, the coil sheath will stop sliding.From this position, you can make it slide again by turning the knob clockwise.When the knob is turned counterclockwise until it stops, and turned again in the same direction with strong force, the knob will bite the slider part and the coil sheath stops sliding.The calculus may not be crushed, and/or the instrument with calculus engaged may not be removed from the body.

Event Description

During a lithotrity, the subject device was used.In the procedure, the subject device was incarcerated.The user crushed the calculus with the emergency lithotriptor.The procedure was completed.There was no further patient injury reported.

• Brand Name: SINGLE USE MECHANICAL LITHOTRIPTOR V
• Type of Device: SINGLE USE MECHANICAL LITHOTRIPTOR
• 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: 8194476
• MDR Text Key: 131772922
• Report Number: 8010047-2018-02534
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K903529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/25/2018

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
• Device Operator: No Information
• Device Model Number: BML-V237QR-30
• Device Lot Number: 76K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1