MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HEAT PROBE

Model Number CD-120U

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The distal tip of the subject device had scratch.The coating of the distal tip became fluffy.The subject device worked.The manufacturing record was reviewed and found no irregularities.The exact cause of the reported event could not be conclusively determined.However, based on the past similar cases, it was known that the user failed to stop bleeding since the coagulated tissue was adhered on the distal tip and the tissue was peeled off from the coagulated site.Also, based on the past similar cases, it was known that the tissue adhered on the distal tip due to any of the following causes.The deterioration of the distal tip coating.The condition of the patient's tissue.The length of the activation time.The output setting of the subject device.The instruction manual of the device has already warned as follows; *it might be impossible to stop bleeding depending on the hemorrhage situation because the probe performance for hemostasis is limited.Prepare more than one hemostatic device and select appropriate hemosratic device or use it together to respond to different hemorrhage situations appropriately.Choose a surgical hemostasis if necessary.

Event Description

During an endoscopic hemostasis, the user failed to stop bleeding with two devices.The intended procedure was completed with the third device.There was no patient injury reported.This is the first one of two reports regarding failure of stopping bleeding.

• Brand Name: HEAT PROBE
• Type of Device: HEAT PROBE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7800181
• MDR Text Key: 117697748
• Report Number: 8010047-2018-01606
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K982289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD-120U
• Device Lot Number: 77K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1