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

Model Number SD-210U-15

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

Patient Problem Electric Shock (2554)

Event Date 06/28/2021

Event Type  Injury  

Manufacturer Narrative

The subject device referenced in this report has not yet been returned to 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

Olympus medical systems corp.(omsc) was informed by the nurse that during an endoscopic mucosal resection using the subject device, the doctor used the yellow pedal, which omsc estimated that is the switch of vio3 erbe, to take off a polyp.The patient jerked immediately and said she felt like an electric shock.The doctor finished cutting off the polyp.Then, they changed the snare from 15mm to a 10mm olympus snare because they took off another polyp.The nurse thought that the snares might be at fault.The engineer from erbe came the next day after the incident and found no fault with the machine.The patient was re-admitted after the procedure due to a post polypectomy bleeding, but the nurse said it was not due to this incident as the patient had a lot of polyps removed.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for investigation.Omsc completed to investigate without the subject device on (b)(6) 2021.Since the lot number of the subject device was unknown, the dhr for over the past year prior to the date of occurrence ((b)(6) 2021) was inspected.No abnormalities detected in the dhr of the following items which relate to the reported phenomenon.Nonconforming product report since this is a known event and the cause can be inferred from the results of previous similar investigations, it was judged that investigation using equipment with similar structure or similar equipment is unnecessary.The instruction manual contains no description related to an electric shock.(gk4000, revision 27).The subject device was combined with an electric surgical generator made by other company.However, the instruction manual of our electric surgical generator (esg-400) contains the following description related to an electric shock.Electrical stimulation of nerves and muscles nerves and muscles can be stimulated by low frequency electrical currents or intense high frequency electrical currents.Low frequency electrical currents may be generated by a partial rectification of intense high frequency electrical current, in particular when there is a spark discharge to the tissue or to another metallic object.Intense high frequency electrical currents can occur at the beginning of an electrosurgical cut or when using high output power settings.This may cause violent spasms or muscle contractions.Use the lowest appropriate power level and effect (e.G.Effect 1 instead of effect 3).However, for certain modes a low output power setting may present an unacceptable risk for the patient.For example, with the pulsecut fast mode or pulsecut slow mode, the risk of an excessive thermal effect rises if the output power setting is too low.High current densities can cause nerve and muscle stimulation.High current densities may occur when modes with high power cut support (hpcs) are used.Nerve and muscle stimulations may cause discomfort or pain in patients without sedation, pain medication or general anesthesia.To reduce the probability of nerve and muscle stimulations use modes without hpcs.The exact cause of the problem could not be conclusively identified by the following reason the device was not retuned for the investigation.No abnormalities were found in the device history record.The subject device was combined with an electric surgical generator made by other company.However, from the instruction manual of our electric surgical generator (esg-400), a likely factor causing the patient to feel an electric shock during energization might be the following.A spark discharge to the tissue or to another metallic object occurred during outputting high frequency.The settings of the high frequency output and coagulation depth were high.On (b)(6) 2021, olympus europa se & co.Kg received the subject device, the evaluation has not been completed yet.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.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was evaluated and investigated by olympus medical systems corp.(omsc).The insertion portion presented no abnormalities that could lead to the reported event.The snare loop presented no abnormalities that could lead to the reported event.Conductivity between the snare loop and the plug presented no abnormalities.The dhr with the lot number of the subject device was confirmed.No abnormalities detected in the dhr for the following items which related to the reported phenomenon.Process inspection sheet.Quality inspection sheet.Nonconforming product report.The exact cause of the problem could not be conclusively identified by the following reason the subject device presented no abnormalities that could lead to the reported event.No abnormalities were found in the device history record.The subject device was combined with an electric surgical generator made by other company.However, from the instruction manual of our electric surgical generator (esg-400), a likely factor causing the patient to feel an electric shock during energization might be the following.A spark discharge to the tissue or to another metallic object occurred during outputting high frequency.The settings of the high frequency output and coagulation depth were high.Although the root cause of this event could not be determined, we will continue to monitor trends and take appropriate actions as necessary.The instruction manual contains no description related to an electric shock.(gk4000, revision 27) the subject device was combined with an electric surgical generator made by other company.However, the instruction manual of our electric surgical generator (esg-400) contains the following description related to an electric shock.Electrical stimulation of nerves and muscles nerves and muscles can be stimulated by low frequency electrical currents or intense high frequency electrical currents.Low frequency electrical currents may be generated by a partial rectification of intense high frequency electrical current, in particular when there is a spark discharge to the tissue or to another metallic object.Intense high frequency electrical currents can occur at the beginning of an electrosurgical cut or when using high output power settings.This may cause violent spasms or muscle contractions.Use the lowest appropriate power level and effect (e.G.Effect 1 instead of effect 3).However, for certain modes a low output power setting may present an unacceptable risk for the patient.For example, with the pulsecut fast mode or pulsecut slow mode, the risk of an excessive thermal effect rises if the output power setting is too low.¿igh current densities can cause nerve and muscle stimulation.High current densities may occur when modes with high power cut support (hpcs) are used.Nerve and muscle stimulations may cause discomfort or pain in patients without sedation, pain medication or general anesthesia.To reduce the probability of nerve and muscle stimulations use modes without hpcs.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, a definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

• Brand Name: DISPOSABLE ELECTROSURGICAL SNARE
• Type of Device: DISPOSABLE ELECTROSURGICAL SNARE
• 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: 12230158
• MDR Text Key: 263607864
• Report Number: 8010047-2021-09379
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 04953170298424
• UDI-Public: 04953170298424
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K902735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: SD-210U-15
• Device Lot Number: V04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization