MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE

Model Number	KD-620QR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus medical system corp.(omsc) for evaluation.On (b)(6) 2018, it was found that the cutting knife was broken off at 0.8mm from the distal end.The manufacturing record was reviewed and found no irregularities.This type of the event is most likely related to the operator's technique.Based on the past similar cases, omsc presumes that the event occurred due to the following occurrence mechanism.Because the cutting knife contacted the tissue at a point during cutting the tissue, the electric discharge occurred.A part of the cutting knife became extremely hot and weak then the cutting knife broke off due to the load.The instruction manual of the device has already warned as follows; aspirate fluids such as mucus that adhere to the electrode and/or the cutting knife, outer sheath and body cavity tissues.Patient injury such as punctures, hemorrhages, mucous membrane damage and thermal injury of tissue could result if output is activated when in contact with these adhering fluids.When current is discharged while the cutting knife is being separated from the mucosa under wet situation, it may break the cutting knife or crack the tip.
Event or Problem Description
During an unspecified procedure, the subject device was used.It was reported that the user could not extend the cutting knife.The intended procedure was completed with another device.There was no patient injury reported.On (b)(6) 2018, it was found that the tip of the cutting knife was broken off.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• Common Device Name: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 7950830
• Report Number: 8010047-2018-01952
• Device Sequence Number: 1381330
• Product Code: KNS
• UDI-Device Identifier: 04953170251504
• UDI-Public: 04953170251504
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K092309
• 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): 10/10/2018

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-620QR
• Device Lot Number: 82K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1