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

Model Number BML-V242QR-30

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The manufacturing history of the subject device was reviewed, with no irregularities noted.Therefore the exact cause of the reported event could not be conclusively determined at this time.If additional information or the device is received a later time, this report will be supplemented.

Event Description

When customer used the subject device like normal and tried crushing a stone, the basket broke inside patient.It broke halfway down the shaft.They removed the handle and scope to use the mechanical lithotriptor ((b)(4)), however due to breaking halfway down the shaft, there was not enough wire outside the patient to use the mechanical lithotriptor ((b)(4)).They then insert the spyglass(other maker's videoscope) and blasted the stone inside the basket and were then able to remove the basket.All parts were retrieved.The patient is fine.

Manufacturer Narrative

The subject device was returned to omsc for investigation on jan.8, 2016.The investigation confirmed that each of coil sheath and tube sheath was deformed.And also, a deformation occurred at the base of the junction between the operating pipe and the operating wire.It is surmised that the wire fractured because the stress that exceeded the durability of the device was applied to it when crushing the calculus.A size and hardness of a calculus are among the factors that may cause the excessive stress.Deformation of the basket was most likely caused by the stress applied upon crushing the calculus.Since there was no abnormality found in the manufacturing history, the subject event was determined to be caused by user handling, but not device malfunction.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.When a force continues to be applied until the lithotripsy fractures, the fracture conditions vary depending on the situation such as the shape of a calculus, bending shape of a coil sheath, etc., so it is not always be fractured at a certain place.This device has these characteristics.Further, 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.), and stop use when any abnormality is detected.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.Warning a lithotriptor cannot always crush all calculi captured in the basket.Operation of this instrument is based on the assumption that open surgery is possible as an emergency measure.If the calculus is too hard, it is possible that the damages shown in chapter 5, "emergency treatment" may occur.Use the lithotriptor by considering that it may lead to damaging the instrument and that open surgery may have to take place; 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 ithotripsy 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, tube sheath not completely retracted in coil sheath etc.).Stop use when any abnormality is detected.

• 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: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 5317376
• MDR Text Key: 34079387
• Report Number: 8010047-2015-01323
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K903529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/22/2016

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-V242QR-30
• Device Lot Number: 57K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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