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

Model Number	KD-V631M-07202S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus medical systems corp.(omsc).The factory of aomori olympus confirmed that the cutting wire of the subject device was broken.The broken section of the cutting wire was melted and burned.As a measurement result of the outer diameter of the cutting wire, there was no abnormality.There were no missing parts.The cutting wire did not pierce the tube.The manufacturing record was reviewed and found no irregularities.It was known that the temperature of the cutting wire increased and the cutting wire broke if the device was activated under the following conditions where the distance between the cutting wire and the tissue was too close or the cutting wire contacted the tissue with a point contact.The above device handling has warned in the instruction.
Event or Problem Description
We received the following report.During endoscopic sphincterotomy, the needle pierced the sheath.The user was unable to pass the device down an endoscope.No patient injury reported.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.On (b)(6) 2020, olympus medical systems corp.(omsc) found that the cutting wire was broken off, and that the broken section of the cutting wire was melted and burned.

• 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
• MDR Report Key: 10738843
• Report Number: 8010047-2020-08173
• Device Sequence Number: 14252065
• Product Code: KNS
• UDI-Device Identifier: 04953170345074
• UDI-Public: 04953170345074
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2020

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: No Information
• Device Model Number: KD-V631M-07202S
• Device Lot Number: 07V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1