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

Model Number BML-V442QR-30

Device Problems Difficult to Remove (1528); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2016

Event Type  malfunction  

Manufacturer Narrative

Based upon our confirmation of the subject device, a distal tip was fallen off.The fallen-off distal tip was found significantly deformed, based upon the investigation of comparing it with a distal tip of brand-new bml-v442qr-30.Accordingly, the cause for the falling-off is speculated to be a mechanism as follows: the distal tip was stuck at a papilla, due to the number, size, and/or location of calculus in the bile duct.Under the above situation, a basket was opened and closed, which put excessive load on the distal tip and resulted in deformation and falling off of the distal tip.As the checking of the manufacturing record of same lot, nothing abnormal was detected.Olympus had checked the all the products of the above distal tip had been correctly connected to the bml-v442qr-30 in the manufacturing processes.Accordingly, olympus judges that nothing abnormal was detected upon shipment of the subject device.

Event Description

The distal tip at the distal end of the lithotriptor was dissolved during the procedure and it has stuck in the papilla.The distal tip was removed with a loop.The doctor exchanged the subject device for another device and completed the procedure.

• 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: 5488096
• MDR Text Key: 39935420
• Report Number: 8010047-2016-00296
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/09/2016

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: Physician
• Device Model Number: BML-V442QR-30
• Device Lot Number: K5910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2016
• Initial Date FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2015
• 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 Age: 75 YR