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

Model Number BML-V437QR-30

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The junction between the operation pipe and the operating wire was broken.There was no abnormality in the welding condition of the junction between the operation pipe and the operating wire.The operating wire was broken at about 925 mm from the distal end.The basket wire was deformed.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that during crushing the calculus, a larger load than durability strength of the product was applied due to the factors such as size, hardness, and shape of the calculus.As a result, the junction between the operating pipe and the operating wire might have broken.The above device handling has been warned in the instruction manual as follows; do not use this instrument for a calculus that is assumed impossible to be crushed by a lithotriptor.The pipe or the basket wire may break and part of this instrument may remain in the body.This instrument will deform and/or deteriorate by performing lithotripsy.When lithotripsy is repeated, it will deform and/or deteriorate furthermore.By such deformation and/or deterioration, calculus may not be crushed and/or the instrument with calculus engaged may not be removed from the body.If lithotripsy is required to be repeated in a single case, make sure to check each time that no abnormality is found in action and/or appearance (e.G.Basket wire cut or worn, tube sheath bent, notable coil sheath bent or gap etc.).Stop use when any abnormality is detected.

Event Description

During an ercp, the subject device was used.The user tried to crush the biliary calculus but the operating pipe of the subject device broke.The user cut the operating wire with a tool, connected the subject device with the emergency lithotriptor, and crushed the calculus.There was no patient injury reported.This is the report regarding the breakage of the operating pipe and the use of the emergency lithotriptor.

• 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: 9479000
• MDR Text Key: 219322502
• Report Number: 8010047-2019-04374
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CLASS2-EXMPT
• 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: 12/17/2019

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: Health Professional
• Device Model Number: BML-V437QR-30
• Device Lot Number: 99K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1