MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)

Model Number	KD-VC611Q-07203S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus¿s local distributor, but not returned to omsc.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed by the customer that during an endoscopic sphincterotomy (est) to remove stones in the bile duct using the subject device, the following event occurred.The papilla was punctured with the device and the wire was placed.Then the device was removed.The wire was left in place.An extraction balloon was pushed into the bile duct over the wire.The black parts were seen at the papilla and it was assumed that the wire was torn off.These parts were recovered with the biopsy forceps.The patient was not injured or harmed.There was no prolongation of the procedure.
Additional Manufacturer Narrative
This supplemental report is being submitted to withdraw mfr report #8010047-2021-07314.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The cutting wire was not broken off.The results of the component analysis revealed that the black part contained components similar to the ptf coating of guidewire.Olympus medical systems corp.(omsc) confirmed that there was no mdr reportable malfunction or adverse event.

• Brand Name: SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)
• 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: 11971462
• Report Number: 8010047-2021-07314
• Device Sequence Number: 14367682
• Product Code: KNS
• UDI-Device Identifier: 04953170399428
• UDI-Public: 04953170399428
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K141991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2021

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: Other
• Device Model Number: KD-VC611Q-07203S
• Device Lot Number: 0XV
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1