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

Model Number SD-210U-25

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

Patient Problem Fever (1858)

Event Date 07/26/2021

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to (b)(4) olympus for the following reasons: the customer discarded the subject device.Although the subject device was not returned for investigation, there was no malfunction reports of the subject device, and it was possible infer its cause.Also, the dhr presented no abnormalities and there have been no similar reports from other facility.Therefore, it was decided that it was not necessary to perform an investigation by using a device with the same structure or a similar device.Since the subject device lot number was unknown, the dhr for over the past year prior to the date of occurrence was inspected.No abnormalities found in the dhr of the following items which relate to the reported phenomenon.Dc resistance value, opening width of the loop, operation force, appearance.Complaint occurrence of the same product and the same phenomenon was investigated.However, there have been no similar reports with the subject device.The subject device could not be confirmed.Therefore, a causal relationship between the subject device and the patient's postoperative fever could not be determined.Since no abnormalities were detected in the dhr, and there have been no reports of device malfunctions, it can be inferred that the reported event did not stem from device abnormalities.A likely factor causing ¿electricity had been flowed through mucous membranes near the tissue to be resected ¿might be the following: a part of the tissue to be resected (e.G., the head area of a polyp) was in contact with the tissue that was not targeted for resection.The snare loop was in contact with the tissue that was not targeted for resection.However, the subject device could not be confirmed, and the root cause could not be determined.Content of the instruction manual (drawing number: gk0240, revision number :27) was confirmed.The instruction manual contains the following descriptions, and it warns against this event.The operator of this instrument must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic technique.This manual, therefore, does not explain or discuss clinical endoscopic procedures.Always operate the electrosurgical unit at the minimum output level and for the minimum time necessary to successfully complete the procedures.Excessive output level and time may result in patient injury, such as punctures, hemorrhages or mucous membrane damage.Aspirate fluids (such as mucus) that adhere to the snare loop and body cavity tissues.If output is activated with these fluids attached, this could cause patient injury, such as punctures, hemorrhages, mucous membrane damage or thermal injury.To avoid burning healthy tissue, do not activate output if the snare loop is in contact with non-target tissue.Do not activate output when any part of the target tissue (a polyp head, for example) is in contact with tissue that is not intended for resection.This could burn the non-target tissue.

Event Description

Olympus medical systems corp.(omsc) was informed by the physician that the sheath of the subject device could not be retracted and the subject device could not be put off a polyp after the surgeon ligated the polyp during a polypectomy on sigmoid colon.The surgeon detached the handle of the subject device and removed the endoscope.The surgeon re-inserted the endoscope and tried to retract the sheath of subject device using a forceps but could not do it.The surgeon used a surgical electronic snare (sd-210u-25) and could cut the polyp at two points (at the upper of and the bottom of snare), because the polyp was large.However, during cutting the polyp at the upper of snare, the mucous membrane in the vicinity was electrically damaged, and fever was observed the next day.The patient was hospitalized four days longer than planned.The surgeon did not use a loop cutter to retract the sheath during the procedure.Omsc will submit a report of hx-400u-30, and another of sd-210u-25.This is the report for sd-210u-25.

Manufacturer Narrative

Aware date is changed from (b)(6).This is because it was (b)(6) 2021 when omsc could found that surgical electronic snare manufactured by olympus was used during the procedure.

Manufacturer Narrative

This supplemental report is being submitted to withdraw mfr report #8010047-2021-11465.On 5th, november, the initiator informed as bellow.The doctor did not estimated that there was a relationship between energizing the mucous membrane in the vicinity and fever.As a result of a fever, the doctor deceded that the patietnt was needed the hospitalization.Olympus medical systems corp.(omsc) confirmed that there was no mdr reportable malfunction or adverse event.

• 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: 12444141
• MDR Text Key: 270630143
• Report Number: 8010047-2021-11465
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 04953170037009
• UDI-Public: 04953170037009
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K902735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SD-210U-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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