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 Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc).The basket wire of the device was divided into three parts (distal, middle and proximal part).Distal part: the operating wire was broken off at about 930 mm from the distal end of the basket wire.The broken part of the operating wire was smooth as if it was cut with a tool.The basket was deformed.Middle part: the length of the wire was about 1010 mm.The distal end of the broken wire was smooth as if it was cut with a tool.Proximal part: the junction between the operation pipe and the operating wire was broken off.There was a cavity at the broken part.The manufacturing record was reviewed and found no irregularities.Based on the past tensile strength test of the device with similar cavity, we judged that there was no abnormality in the strength of the junction between the operation pipe and the operating wire.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 be broken.It is surmised that the deformation of the basket occurred due to a load when crushing the calculus.The instruction manual of the device has already warned 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 endoscopic retrograde cholangiopancreatography, the subject device was used.It was reported that the physician tried to crush the calculus with the device, but the basket wire of the device was broken off, it fell into the patient body and the device was incarcerated.The physician used emergency lithotriptor and retrieved the device together with the fragment.The intended procedure was completed.There was no 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: 8195247
• MDR Text Key: 131934206
• Report Number: 8010047-2018-02558
• 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: 12/26/2018

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-V437QR-30
• Device Lot Number: 87K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2018
• 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