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

Model Number	KD-V631M-07202S
Medical Device Problem Codes	Break (1069); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.¿.
Additional 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
• Common Device Name: 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
• Report Number: 8010047-2022-04585
• Device Sequence Number: 5033322
• Product Code: KNS
• UDI-Device Identifier: 04953170403187
• UDI-Public: 04953170403187
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown