MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE ELECTROSURGICAL SNARE

Model Number	SD-240U-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bowel Burn (1756)
Date of Event	10/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined at this time.However, based on similar reported events, the most probable cause may be attributed to operator technique.The instructions for use provides warnings and caution statements in an effort to prevent equipment damage and patient injury.¿before use, make sure that the snare wire is not frayed; do not use it if this or any other irregularity is observed.Otherwise, the snare loop may break and could cause punctures, hemorrhages and/or thermal injury to non-target tissue.¿.
Event or Problem Description
Olympus was informed that during a polypectomy procedure, while removing a small polyp the patient sustained a burn.It was reported that everything seemed to be going fine, until the facility¿s computer began to flash during the procedure.The staff did not note any bleeding or any other issue with the patient at that time.However, at the completion of the procedure the patient began to complain of severe abdominal pain.The patient was retained for observation for an unknown period to determine if the pain was attributed to gas.The patient was then sent to the hospital to undergo a cat scan, which revealed no abnormalities.It was determined that the patient¿s pain was likely due to a burn.The user facility reported that the patient was in their mid-40's to early 50's and that no additional medical or surgical intervention was required.The patient was discharged home the same day with no further complications.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the original equipment manufacturer (oem).Since the device was not returned and the device lot number is unknown, the oem performed a review of the device history records (dhr) from one year previous to the reported event and found no anomalies during the manufacturing relating to the reported event.Due to the device not being returned, the cause of the reported event cannot be determined; however, the oem referenced the following details found in the instruction manual.When using an electrocardiograph or other physiological monitoring equipment simultaneously with the instrument and a-cord on a patient, any monitoring electrodes should be placed as far away as possible from the electrodes used with the electrosurgical unit.Needle monitoring electrodes should not be used, as they may cause patient burns.Physiological equipment incorporating a high-frequency current limiting devices are recommended.Do not activate output if any of the patient¿s skin surfaces are touching each other (the bare arm and the side of the chest, for example).This could burn the patient.Do not activate output when the patient is in contact with metal parts of the operating table or other units.This could burn the patient, operator or assistant.
Additional Manufacturer Narrative
This supplemental report is being submitted to make a correction on the pro code from fas to fdi.

• Brand Name: DISPOSABLE ELECTROSURGICAL SNARE
• Common Device Name: DISPOSABLE ELECTROSURGICAL SNARE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7987501
• Report Number: 2951238-2018-00634
• Device Sequence Number: 1858676
• Product Code: FDI
• UDI-Device Identifier: 04953170298455
• UDI-Public: 04953170298455
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K955650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SD-240U-15
• Device Catalogue Number: SD-240U-15
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 11/07/2018; 02/20/2019
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 11/13/2018; 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other