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 Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the lot number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there was no description of the device's malfunction.

Event Description

On october 15, 2020, olympus medical systems corp.(omsc) received literature titled "letters,techniques and images endoscopic shielding technique using polyglycolic acid sheets with fibrin glue for perforation following endoscopic ampullectomy".The purpose was to report a perforation following endoscopic ampullectomy which was successfully treated with filling and shielding by polyglycolic acid (pga) sheets and fibrin glue.In the literature, it was reported that one perforation and bleeding two days after endoscopic ampullectomy was observed.The patient also presented with abdominal pain and, free air was revealed by ct at the same time.The author wrote, "after endoscopic hemoclip treatment, the perforation was filled with pga sheets to protect it from exposure to bile and pancreatic juice.Fibrin glue was then sprayed over the site to allow the pga sheets to adhere to the area.In addition, a nasobiliary drainage (enbd) tube was placed to reduce bile exposure." the esd procedures was performed using an electrosurgical snare (sd-210u-25; olympus).Based on the available information, a direct relationship between the olympus product and the observed adverse event could not be determined.However, according to the figures, the area of a perforation looked the same area of using an electrosurgical snare.

• 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: 10827555
• MDR Text Key: 216109323
• Report Number: 8010047-2020-08846
• Device Sequence Number: 1
• Product Code: FDI
• 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: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SD-210U-25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2020
• 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): Other
• Patient Age: 88 YR