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

Model Number CD-120U

Device Problems Break (1069); Energy Output To Patient Tissue Incorrect (1209)

Patient Problem Blood Loss (2597)

Event Date 09/08/2016

Event Type  Injury  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.There was a scratch and a peeling of the coating on the probe.Also there was a buckling on the insertion portion.As the result of checking the manufacturing record of the same lot, there was nothing abnormal detected.Based on the evaluation and similar cases in the past, the bleeding might not be stopped because the coating of the probe deteriorated due to a repeatedly use.In addition, it was presumed that the tissue stuck on the probe under the influence of the condition of the tissue, the energization time, or the output setting on the high frequency generator.The buckling might be caused by excessive stress applied to the insertion portion while inserting the subject device into the endoscope or reprocessing the subject device.The instruction manual of the subject device warns; do not touch the bleeding site abruptly.This could result in more-severe bleeding and puncture; do not increase over the energy selector level.This could result in bleeding and puncture; when inserting the instrument into the endoscope, hold it close to the biopsy valve and keep it as straight as possible relative to the biopsy valve.Otherwise, the insertion portion could be damaged.

Event Description

During a polypectomy, it was informed that the doctor could not stop bleeding with the subject device.The patient was transferred to another hospital.The patient was a temporarily serious condition, but the bleeding of the patient could be stopped with the similar device in the transferred hospital.The patient already recovered.

• Brand Name: HEAT PROBE
• Type of Device: HEAT PROBE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6002041
• MDR Text Key: 56535490
• Report Number: 8010047-2016-01284
• 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: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: CD-120U
• Device Lot Number: K2511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2012
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other