MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE PRELOADED SPHINCTEROTOME V

Model Number KD-V631M-07202S

Device Problems Break (1069); Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2022

Event Type  malfunction  

Event Description

It was reported the customer tried to utilize the main handle, handle would not move and wire fell out.The device was replaced and the intended procedure was completed with a second like device.There was no patient harm or injury reported due to the event.No user injury reported.

Manufacturer Narrative

The subject device was not returned for evaluation.The cause of the reported issue is unknown at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.¿.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, possible causes may include: the cutting wire was pulled tightly when the distal end of the tube was not deflecting enough.A tensile load applied to the press fitted area of the distal tip.This caused the distal tip to detach from the tube.Some loads were applied to the cutting wire after the distal tip was detached from the tube.This caused the cutting wire to break and fall off.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

• Brand Name: SINGLE USE PRELOADED SPHINCTEROTOME V
• Type of Device: SINGLE USE PRELOADED SPHINCTEROTOME
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13796794
• MDR Text Key: 287346887
• Report Number: 8010047-2022-04585
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170403187
• UDI-Public: 04953170403187
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KD-V631M-07202S
• Device Lot Number: 0ZV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2022
• 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