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

Model Number BML-V237QR-30

Device Problems Difficult to Remove (1528); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/27/2016

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the olympus.The device was disassembled to four parts: basket wire, tube sheath, operation pipe and coil sheath.They were returned to olympus together.As an investigation result, the basket wire was cut off about at 2160mm from the distal end.The basket was deformed.The tube sheath was cut off about at 2030mm from the distal end.The cutting surface was a torn-edge.The distal end of the tube sheath was deformed.The coil sheath had buckled at the distal and proximal side.Move of the coil sheath was unsmooth and accompanied with resistance.It was impossible to slide the knob on the handle to the distal end of the groove of the slide region.It was found that the tube sheath had a compressive buckling at the joint between the slider.The over-pipe to contain the tube sheath was deformed and torn.When the coil sheath and tube sheath were placed side by side to compare lengths, it was found that the tube sheath was longer than the coil sheath.As a review of manufacturing history of the product with lot number of the complaint device, there was no abnormal result not meeting the following acceptance criteria relating to the reported event.(lot#:k6304) no buckling on the tube sheath.Cut length of the tube sheath should be within the specification.The coil sheath should move smoothly, with the insertion portion forming double loops.It is surmised that the tube sheath got stuck due to the following sequential causes.The tube sheath got an excessive load to elongate in the use of the complaint device.The tube sheath could not be completely withdrawn into the coil sheath because of the elongation of the tube sheath.Crushing stone was attempted while the tube sheath was come out of the distal end of the coil sheath.The tube sheath got a compressive load and buckled.Due to the buckling, the basket wire and coil sheath became inoperative and the tube sheath got stuck.It is surmised that the tube sheath got elongated or deformed due to the following sequential causes.The root of the basket was significantly bent due to raising the forceps elevator of the endoscope or pushing the basket against the intestinal wall.Because opening the basket was attempted in the condition above, frictional resistance between the basket wire and tube sheath became larger.The basket was pushed out in spite of the condition above, and the tube sheath was also pulled together and got elongated.Description of instruction manual.Warning.When the lithotriptor¿s basket does not smoothly open or close, do not apply force but move the forceps elevator or the scope¿s angle back, or move the position of the basket until the basket opens or closes with ease.If the action is forced, the tube may stretch and cannot be stored inside the coil sheath.Also, the calculus may not be crushed, and/or the instrument with calculus engaged may not be removed from the body.

Event Description

Olympus medical system corp.(omsc) was informed that during endoscopic lithotripsy for biliary stones, the doctor attempted to crush two calculi held inside the basket, but the tube sheath got elongated and got stuck.The doctor used a mechanical lithotriptor (bml-110a-1) following the instructions.The doctor eventually crushed two calculi and released the stuck tube.Since the use of bml-110a-1 released the stuck tube, there was no patient injury reported regarding this event.

• 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: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 8142642517
• MDR Report Key: 6265684
• MDR Text Key: 65666330
• Report Number: 8010047-2017-00061
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK903529
• 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

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-V237QR-30
• Device Lot Number: K6304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Initial Date Manufacturer Received: 12/27/2016
• Initial Date FDA Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2016
• 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