MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE PAPILLOTOMY KNIFE

Model Number	KD-211Q-0725
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device referenced in this report was not returned to olympus medical systems corp.(omsc) for evaluation.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
During an endoscopic retrograde cholangiopancreatography, the subject device was used.The distal end of the subject device broke and fell off.The intended procedure was completed with another device.There was no patient injury reported.It was also reported that the distal end of the subject device did not fall into body.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.The manufacturing record was reviewed and found no irregularities.Based on the event description and the similar cases in the past, it can be inferred that the reported event indicates the detachment of the distal tip from the tube.However, the phenomenon could not be identified.Based on the similar cases in the past, there is a possibility that the cutting wire was pulled tightly when the distal end of the tube was not deflecting enough.As a result, a tensile load applied to the press fitted area of the distal tip.This caused the distal tip to detach from the tube.A likely mechanism causing the cutting wire falling outside the body might be the following.The cutting wire was spreading outward due to the detachment of the distal tip from the tube.The spread cutting wire was broken and fell off due to contact the scope¿s lumen or biopsy valve when extracting the device from the endoscope.The above device handling has warned in the instruction manual.

• Brand Name: DISPOSABLE PAPILLOTOMY KNIFE
• Common Device Name: DISPOSABLE PAPILLOTOMY KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10808477
• Report Number: 8010047-2020-08699
• Device Sequence Number: 4011901
• Product Code: KNS
• UDI-Device Identifier: 04953170040337
• UDI-Public: 04953170040337
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K950166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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-211Q-0725
• Device Lot Number: 02K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR