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

Model Number BML-V437QR-30

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 12/25/2020

Event Type  Injury  

Manufacturer Narrative

The subject device referenced in this report was not returned to olympus medical systems corp.(omsc) 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 Description

During a lithotrity, the subject device was used.It was reported that the shaft which was connected to the handle was broken off since the calculus was hard.The user became unable to remove the subject device, and switched to the open surgery.Patient had good prognosis.

Manufacturer Narrative

This is a supplemental report to provide additional information.It was additionally reported that two devices were used for the same procedure.The subject device was broken but could be removed from the patient.The user exchanged it for the second device and continued the procedure.The user became unable to remove the second device, and switched to the open surgery.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The basket wire and operation pipe had been removed from the sheath.Misalignment of the coil was discovered at the distal end of the coil sheath.Investigation was carried out by connecting an aomori olympus bml-v437qr-30 and the returned handle.Installation of the handle was completed without any problems.The manufacturing record was reviewed and found no irregularities.As a result of evaluation, omsc concluded that the reported event on the subject device was not reportable event.

• 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
• MDR Report Key: 11175697
• MDR Text Key: 230309712
• Report Number: 8010047-2021-01436
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

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
• Device Operator: Health Professional
• Device Model Number: BML-V437QR-30
• Device Lot Number: 08K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/25/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention