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

Model Number SD-240U-15

Device Problem Output Problem (3005)

Patient Problem Perforation (2001)

Event Date 01/25/2017

Event Type  Injury  

Manufacturer Narrative

The referenced snare was not returned to olympus as the user facility discarded the snare right after the procedure.Therefore, the exact cause of the reported event could not be conclusively determined.

Event Description

The user facility reported that after a therapeutic colonoscopy procedure, the patient was admitted to the hospital later in the day with severe abdominal pain and was diagnosed with a perforated colon.The user facility stated the esu possibly malfunctioned as the esu was showing signs of abnormal cutting/coagulation when using a snare to remove a 1.2cm sessile polyp close to the polypectomy side of the transverse colon.The esu settings were at 25.No error messages were noted prior to the reported event.The patient was admitted to (b)(6) hospital for a colectomy and surgical repair.The patient currently has been discharged home.In addition, the patient had colonic polyps on previous colonoscopy in 2004 and has a history of hyperlipidemia, hypothyroidism, and diverticular disease.Two of 2.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from fas to fdi.

• 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
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6348139
• MDR Text Key: 67923956
• Report Number: 2951238-2017-00107
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK902735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: SD-240U-15
• Device Catalogue Number: SD-240U-15
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• 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
• Treatment: MA-255, LOT# UNKNOWN; PCF-H180AL, SN# (B)(4); PSD-20, SERIAL# (B)(4)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 67