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

Model Number BML-V237QR-30

Device Problem Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for investigation.In the investigation, the reported phenomenon could not be confirmed because the knob of the subject device could slide.The basket wire was deformed.The basket wire was cut at 180 mm from the distal end.The operating pipe side of the basket wire was not returned to omsc.The groove of the middle part of the slider was deformed.The device history record for the lot indicated no abnormality with the event-related items.Based on the similar cases in the past, it is surmised that the knob did not slide because the knob stuck to the slider when the knob was loosened too much.It is surmised that the deformation of the basket wire occurred due to a load while crushing the calculus.It is surmised that the deformation of the groove of the slider occurred since the knob was loosened too much.The instruction manual of the device has already warned as follows; do not forcibly loosen the knob.Otherwise, the knob could be damaged.

Event Description

During an endoscopic retrograde cholangiopancreatography, the subject device was used.It was reported that the physician could not crush the calculus because the knob of the subject device did not slide when the physician tried to crush the third calculus.The physician retrieved the subject device 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: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6885636
• MDR Text Key: 89419505
• Report Number: 8010047-2017-01363
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK903529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2017

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: K7406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2017
• 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