MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE PAPILLOTOMY KNIFE

Model Number	KD-211Q-0725
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned to olympus for evaluation.The knife wire was discarded immediately; therefore, the complaint could not be confirmed.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported device problem.The dhr confirmed that the subject device was shipped in accordance with the specifications.The definitive root cause could not be determined.Based on similar investigation result in the past, the breakage of the cutting wire was likely due to the following mechanisms: 1) the device was energized in one of these following situations.(a) the cutting wire is in point contact with tissue, or they were close to each other.(b) the cutting wire is in point contact with distal end of endoscope or they were close to each other.2) an electrical discharge occurred in the cutting wire, and the cutting wire became hot instantly.3) the cutting wire was broken.The instruction manual provides the following: ¿·since the cutting wire is very thin, it may break off in the following cases: the distance between the papilla of vater and the wire is very short, the output is too high or activated while the wire touches metal parts of the endoscope, or the wire is tightened too strong.When the wire breaks off, its proximal end will be retracted toward the endoscope if the slider is pulled.If the slider is pushed, the wire will be pushed out toward the papilla or jumps sideways.If the wire breaks off, stop the output immediately and pull the slider completely to retract the broken wire into the tube.Then withdraw the instrument from the papilla.Otherwise, patient injury, such as perforation, bleeding or lacerations within the biliary duct and/or damage of the endoscope could result.·be sure that the rear end of the cutting wire is extended from the distal end of the endoscope.Insufficient output or unintended tissue injury may occur in case the cutting wire contacts the forceps elevator.·always operate the electrosurgical unit at the minimum output level and for the minimum time necessary to successfully complete the procedures.Excessive output level and time may result in patient injury, such as perforation, bleeding or mucous membrane damage.It could also damage the instrument.¿ olympus will continue to monitor field performance for this device.
Event or Problem Description
A customer reported to olympus, during a therapeutic endoscopic retrograde cholangiopancreatography (ercp), the knife wire broke after the third energization.The procedure was completed using a replacement device.There was no report of patient injury or harm associated with this event.

• Brand Name: DISPOSABLE PAPILLOTOMY KNIFE
• Common Device Name: DISPOSABLE PAPILLOTOMY KNIFE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17100925
• Report Number: 9614641-2023-00831
• Device Sequence Number: 7690405
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2023

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-211Q-0725
• Device Lot Number: 1ZK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 06/09/2023
• 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