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

Model Number BML-V442QR-30

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The distal tip of the subject device was detached.Adhesive was properly applied to connect to the distal tip.The manufacturing record was reviewed and found no irregularities.Based on the similar cases in the past, it is surmised that the adhesive between the distal tip and basket wire was peeled when the part near the distal tip was bent.As a result, the distal tip was detached from the distal end of the basket.The instruction manual of the device has already warned as follows; when using the guide wire, insert the instrument with its distal tip in parallel with the guide wire while holding the distal tip as shown in figure 4.20.Be careful not to forcibly insert the instrument with a sharp angle between the distal tip and the guide wire as shown in figure 4.21.This may damage the distal tip.

Event Description

During a cholelithotripsy, the subject device was used.It was reported that the basket wire of the subject device was broken.The physician removed the subject device from the patient body.There was no patient injury reported.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.As a result of the investigation on (b)(6) 2017, omsc found that the distal tip of the subject device was detached.Regarding the reported event, there was no report whether the fragment fell into the bile duct or not.This is the report regarding the detachment of the distal tip.

• 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: 7150009
• MDR Text Key: 96225905
• Report Number: 8010047-2017-02129
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/28/2017

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-V442QR-30
• Device Lot Number: 76K
• Other Device ID Number: 04953170218422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• 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