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

Model Number BML-V232QR-30

Device Problem Difficult to Remove (1528)

Patient Problem Injury (2348)

Event Date 02/12/2016

Event Type  Injury  

Manufacturer Narrative

The doctor surmises that the sheath part of the subject device where compressive load was applied was released by removing bml handle ((b)(4)), and the endoscope was able to be withdrawn with bml-v232qr-30.By this, the doctor executed the surgery in order to treat the torn papilla.As described in the instruction manual, this device is not designed to be capable of crushing all calculus.Consequently, the pipe or basket wire may break and part of the lithotriptor may remain in the body.Different parts of the device break depending on the situation such as the shape of a calculus, bending shape of a coil sheath, etc.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, notable coil sheath bent or gap etc.).

Event Description

(first event): the doctor performed a lithotripsy using bml-v232qr-30, and a wire at a wire joint with a pipe snapped.Since a calculus was released from a basket wire, it did not lead to incarceration.(second event): the doctor again performed a lithotripsy using another bml-v232qr-30, and succeeded in it.However, coil sheath was kinked at approximately 50 mm from the tip of the sheath, and the subject device was not able to be withdrawn from an endoscope.The doctor attempted to withdraw the subject device from a bile duct by pushing and pulling the endoscope back and forth at a papilla, without success.Then, the doctor found out that the papilla was torn.(third event): after confirming that the papilla was damaged, the doctor removed a bml handle ((b)(4)) and was able to remove bml-v232qr-30 through the instrument channel outlet of the endoscope.Then, the doctor withdrew the endoscope from the patient's body.In an effort to treat the damage of the papilla, the doctor performed an open surgery.This report describes the "third event".Please cross-reference the following report; 8010047-2016-00319, 00321.

• Brand Name: OLYMPUS SINGLE USE MECHANICAL LITHOTRIPTOR V
• Type of Device: MECHANICAL LITHOTRIPTOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORP.; 2951; ishikawa-cho,; hachioji-shi, tokyo 192-8 502; JA 192-8502
• Manufacturer Contact: kunimori yamaguchi ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 5494389
• MDR Text Key: 40114236
• Report Number: 8010047-2016-00322
• 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: Physician
• Type of Report: Initial
• Report Date: 03/11/2016

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: Physician
• Device Model Number: BML-V232QR-30
• Device Lot Number: K5918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 03/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2015
• 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
• Patient Outcome(s): Other