MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ELECTROSURGICAL UNIT

Model Number UES-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 01/13/2021

Event Type  Injury  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Based upon the information from olympus (b)(4) there was the possibility that the reported phenomenon was attributed to the increasing the temperature due to the insufficient contact which was caused by the fluid, floating and/or detaching between the patient's skin and the patient plate.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed following from the user.The user performed the conization of the cervix with the subject device and non-olympus (not recommended) patient plate.The patient plate was attached to the patient's leg.The output mode of the subject device was coagulation and the output levels were 45 (cut) and 55 (coagulation).The procedure was completed.Thirty minutes after the procedure, the patient complained of the burn to the user.The patient's burn was approximately one square centimeter area on the leg where the patient plate had been attached, also the skin was broken and the part of skin was blackened.There was no report that the function of the subject device had any abnormality.

• Brand Name: ELECTROSURGICAL UNIT
• Type of Device: ELECTROSURGICAL UNIT
• 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: 11306660
• MDR Text Key: 231122538
• Report Number: 8010047-2021-02482
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UES-40
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1