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

Model Number BML-V437QR-30

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

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 05/29/2017

Event Type  Injury  

Manufacturer Narrative

The basket wire of the subject device was returned to olympus medical systems corp.(omsc).Omsc investigated it on june 13, 2017.The basket wire with 34mm length from the distal end was ductile fracture.The outer diameter of the basket wire was found no irregularities.The manufacturing records were reviewed retrospectively for one year from the delivery date since the lot number of the subject device was unknown, and found no abnormality on the following items.Outer diameter of the basket wire, deformation of the basket wire, outer diameter of the operating wire, overflowed length of the brazing filler at the brazed part, outer diameter of the brazing part, outer appearance of the brazing part, opening length of the basket, retractivity (retractive performance) of the basket.Based on the similar cases in the past, it is likely that the basket wire was broken since the excess load for the crushing calculus was applied due to hardness, shape or size of the calculus.

Event Description

On (b)(6) 2017, the subject device was used during crushing a calculus in the bile duct.The doctor tried to crush the calculus using the subject device after performing the endoscopic papillotomy, but some basket wires of the subject device were broken, and then the subject device was incarcerated.The doctor tried to crush the calculus using bml-110a-1(emergency lithotripter), but all of the remaining basket wires were broken.The doctor pulled the remaining wires using the forceps, but could not retrieved the remaining wires.The distal end of basket wires remained in the bile duct with the stone.The doctor placed the stent in the bile duct, and interrupted the procedure.On (b)(6) 2017 the doctor performed the open surgery, and then retrieved the remaining wires and the calculus.

• 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: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6649521
• MDR Text Key: 77828791
• Report Number: 8010047-2017-00744
• 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: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2017

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: No Information
• Device Model Number: BML-V437QR-30
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 06/19/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR