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

Model Number BML-V437QR-30

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 07/19/2013

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to omsc for investigation.The investigation confirmed that the pipe was broken at the junction with the wire.There were no abnormalities found upon investigation of the condition of the connection part.As the result of checking the manufacturing record of the same lot, there were also no abnormalities noted that may lead to the breakage.The calculus turned out to be hard according to the report by facility.Therefore, omsc considers that the calculus was too hard to crush and it caused the breakage of the lithotripter.The device instruction manual has warned users that there is possibility the calculus cannot be crushed by lithotriptor, and it also describes what to do if the lithotriptor cannot crush the calculus.This report is being submitted as a medical device report in an abundance of caution.

Event Description

Olympus medical systems corp (omsc) was informed that the doctor attempted to crush the calculus in the bile duct with the lithotripter but he couldn't, and then the lithotripter was broken.Since he tried to crush the calculus with using bml-110a-1 but he failed again.He abandoned the procedure as the basket wire remained in the pt.The next day, the doctor performed open surgery to retrieve the basket wire and calculus from the pt.The pt is in the hospital and reportedly will be discharged soon.

• Brand Name: OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V
• Type of Device: MECHANICAL LITHOTRIPTOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi 192- 8507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 3305694
• MDR Text Key: 18567631
• Report Number: 8010047-2013-00242
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BML-V437QR-30
• Device Catalogue Number: BML-V437QR-30
• Device Lot Number: 36K
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/22/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR