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

Model Number SD-12U-1

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

Patient Problem Hemorrhage/Bleeding (1888)

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 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.

Event Description

On (b)(6) 2021, olympus medical systems corp.(omsc) received the literature titled "evaluation of factors associated with en bloc colonic underwater endoscopic mucosal resection".The purpose of this literature was to evaluate the factors associated with a successful en bloc resection using underwater endoscopic mucosal resection (uemr) to provide information for the clinicians to select which patients are eligible for uemr.In the literature, it was reported as follows; the study comprised 160 patients who were 173 colorectal polyps were removed with uemr.Of all 160 patients, 101 (63.1%) patients were male, and the mean age was 65.17 ± 11.73 years old (range: 30-91 years old).Thirteen (7.5%) of the patients had more than one polyp during the procedure and received more than one uemrs.Colonoscopies were performed with a conventional colonoscope (cf-q260al, cf-h290l) or a magnifying pediatric colonoscope (pcf-q260azi).A transparent hood (d-201-13 404) was applied for every colonoscopy.An oval standard polypectomy snare (sd-12u-1, sd-210u-25, or sd-230u-20) was used depending on the lesion size.After the polyp was firmly snared, the surgeon resected it with an interrupted cut cycle (esg-100 pulsecut slow 60 w).No submucosal injection was used during the uemr.For polyps that could not be removed as a single piece, the surgeon used piecemeal uemr until the resection was complete.Hemoclips (ez clip) were routinely used to close the mucosal defects.Follows complications were reported.Delayed bleeding - (2).Muscle defects requiring endoscopic clipping - (3).Delayed perforations - (1).Polyp recurrences - (4).Based on the available information, reported these complications were not reported in a direct relationship with the olympus products.However, omsc assumes that the delayed bleeding, the muscle defects, and the delayed perforations might be related to the subject device since the subject device was used for the procedure.The muscle defects were not serious injuries due to closed a muscular layer defect with hemoclips.Whereas, omsc assumes that the delayed bleeding and the delayed perforations were serious injuries since these complications might be caused or contributed to a death or serious injury.In this literature, delayed bleeding was defined as any clinical evidence of lower gastrointestinal bleeding within 14 days after the uemr that required blood transfusion, colonoscopy, or hospitalization.And the delayed perforation needed laparoscopic colon repairment.Based on the available information, specific information on the subject device was not provided.Follows information of patients were reported.(b)(6) male (b)(6) delayed perforation needed laparoscopic colon repairment.(b)(6) male (b)(6) delayed bleeding.(b)(6) female (b)(6) delayed bleeding.Therefore, omsc assumes that the 2 delayed bleeding and the delayed perforations were adverse events to submit 3 medical device reports (mdrs) of the subject device.There is no description of the device's malfunction.This report is regarding the bleeding of patient no.145.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to g2.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

• Brand Name: ELECTROSURGICAL SNARE
• Type of Device: 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: 12998247
• MDR Text Key: 282192272
• Report Number: 8010047-2021-16074
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04953170036460
• UDI-Public: 04953170036460
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K955650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SD-12U-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female