MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN NEEDLE KNIFE V

Model Number KD-V441M

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2021

Event Type  malfunction  

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 Description

During a procedure, the subject device was used.At the first output, the cutting knife of the subject device broke and fell.The fragment was retrieved.The intended procedure was completed with another device.There was no patient injury reported.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The fracture surface of the knife was melted and burnt.The length of the knife was measured.About 2 mm size of the knife was missing.The missing part was not returned.The outer diameter of the knife was measured.The result indicated no abnormalities.No other abnormalities were confirmed.  the manufacturing record was reviewed and found no irregularities.Based on the past similar cases, omsc presumes that breakage of the knife was caused by the high temperature of the knife since discharge was generated due to the following factors during tissue incision.The output setting was high.The energizing time was long.The knife was not kept moving.The contact length between the tissue and the knife was short.The above device handling has warned in the instruction manual.

• Brand Name: SINGLE USE 3-LUMEN NEEDLE KNIFE V
• Type of Device: SINGLE USE 3-LUMEN NEEDLE KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11336351
• MDR Text Key: 232805300
• Report Number: 8010047-2021-02712
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K955247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

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
• Device Operator: Health Professional
• Device Model Number: KD-V441M
• Device Lot Number: 0XK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1