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

Model Number SD-210U-10

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

Patient Problem Sepsis (2067)

Event Type  Injury  

Event Description

On oct.22, 2021, olympus medical systems corp.(omsc) received the literature titled "multicenter cohort study of patients with buried bumper syndrome treated endoscopically with a novel, dedicated device".This study was conducted on 54 patients (55 procedures) with buried bumper syndrome (bbs) treated with the flamingo device between december 2016 and february 2019.The median age of the patients was 66 years (range, 17-94 years), and 42 patients were men.In the literature, it was reported that the following.Periprocedural endoscopic adverse events occurred in 7 procedures.Significant bleeding occurred in 4 patients; this was treated with epinephrine injection in 1 patient, application of endoclips in 1 patient, and use of an over-the-scope clip (otsc) in 2 patients.A small perforation occurred in 2 patients, 1 of which was closed with multiple endoclips once the peg was removed and 1 of which was treated conservatively.A superficial laceration of the gastroesophageal junction (gej) was diagnosed during peg extraction in 1 patient and treated conservatively.Sepsis was the only postprocedural adverse event within 48 hours from the buried bumper removal, occurring in 2 patients; it was managed successfully with intravenous antibiotics for 5 days.Four patients died after a median of 35 days (range, 33-175) from unrelated conditions.Apart from the flamingo set, 47 additional devices (eg, snare, forceps, balloon) were used in 40 procedures to facilitate the insertion of the guidewire and the flamingo device through the granulation tissue covering the internal bumper.The snare was sd-210u-10 or sd-210u-15.Based on the available information, reported significant bleeding, small perforation, superficial laceration, death were not reported in a direct relationship with the olympus products.However, omsc assumes that the sepsis might be related to the subject device since the subject device was used for the procedure.And, omsc assumes that the sepsis might be caused or contributed to a death or serious injury.Omsc assumes that the significant bleeding, the small perforation and the superficial laceration were not serious due to the following report: significant bleeding occurred in 4 patients, this was treated with epinephrine injection in 1 patient, application of endoclips in 1 patient, and use of an over-the-scope clip (otsc) in 2 patients.Small perforation occurred in 2 patients, 1 of which was closed with multiple endoclips once the peg was removed and 1 of which was treated conservatively.Superficial laceration of the gastroesophageal junction (gej) was diagnosed during peg extraction in 1 patient and treated conservatively.Omsc assumes that the death might be not related to the subject device due to the following report: four patients died after a median of 35 days (range, 33-175) from unrelated conditions.Therefore, omsc assumes that the sepsis was an adverse event to submit.Based on the available information, specific information on the subject device and the patient (except for some, for example, age) were not provided.There is no description of the device's malfunction.This is the report regarding 2 cases of sepsis.

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 serial 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 is no description of the device's malfunction.

• 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: 12777444
• MDR Text Key: 280510966
• Report Number: 8010047-2021-14311
• Device Sequence Number: 1
• Product Code: FDS
• 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,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: SD-210U-10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2021
• 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): Required Intervention; Hospitalization