MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORP. OLYMPUS 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 11/24/2016

Event Type  malfunction  

Manufacturer Narrative

Since the actual product was not returned to olympus for evaluation, an investigation was performed on (b)(6) 2016, based on the pictures.The reported event was confirmed in the following pictures: a picture of the deformed the distal tip.A picture of the deformed the basket wire.As a result of dhr review of the same lot of the product, there was no irregularity in distal tip assembly which is relating to the reported event.Since the actual product was not returned to olympus, the assumed causes are described below based on the similar cases in the past.Sequential causes of falling off of the distal tip in the patient.The subject device was removed while the inserted guide wire was bent in the duodenum, which caused forming a loop in the guide wire around the distal end of the distal tip.The distal tip tangled to the loop in the guide wire, and withdrawal of the basket became impossible.Because attempt to remove the subject device was continued, the distal tip fell off from the distal end of the basket.Cause of deformation of the distal tip.While the basket was being removed, or the fell off distal tip was being retrieved with forceps, the cup of the forceps gave the distal tip a crushing force to be deformed.Cause of deformation of the basket.When the basket wire grasped calculi, the deformation of the basket occurred, because a force beyond the strength limit was applied to the basket.There is the following description in the instruction manual.Warning 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

The subject device was used for the ercp stone crushing.When the doctor was trying to trawl the duct, the distal tip was damaged and fell off in the patient.The distal tip was removed and the doctor completed the procedure.There was no patient injury reported.

• 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: kunimori yamaguchi ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6188102
• MDR Text Key: 62799921
• Report Number: 8010047-2016-01563
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Other
• Type of Report: Initial
• Report Date: 12/20/2016

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: 65K
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2016
• Initial Date FDA Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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