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

Model Number SD-240U-25

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined at this time; however, this type of reported phenomenon is most likely related to the operator's technique.The instruction manual warns users to: "pull the slider to confirm that the distal end of the snare loop is completely retracted into the snare tube.When using the instrument while the snare loop is not completely retracted into the snare tube, the strangulation becomes insufficient and the tissue may not be resected completely and hemorrhages, punctures, or mucous membrane damage could result.In addition, it may be impossible to remove the snare loop from tissue due to burn on tissue.The instruction manual also states to always have pliers ready to cut the insertion portion in case the snare loop cannot be removed from snared tissue." if additional information becomes available at a later time, this report will be supplemented.

Event Description

Olympus was informed that during a polypectomy procedure, the snare became stuck the patient¿s polyp.The polyp was considered to be moderate in size and firm.There was no bleeding observed.The physician used pliers and applied force to remove the snare loop.The polyp was close to the patient¿s rectum, so the physician was able to remove it.The intended procedure was completed with a similar device.The patient's current condition is stable.Additionally, the snare was tested with current prior to the procedure with no anomalies noted.

• 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: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8525484
• MDR Text Key: 142358120
• Report Number: 2951238-2019-00745
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 04953170165986
• UDI-Public: 04953170165986
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD-240U-25
• Device Lot Number: 71V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2019
• 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: Initial
• Patient Sequence Number: 1