MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE ELECTROSURGICAL SNARE

Model Number SD-210L-25

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

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

Event Date 04/28/2021

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled, "circumferential submucosal incision prior to endoscopic mucosal resection versus conventional endoscopic mucosal resection for colorectal lesions with endoscopic features of sessile serrated lesions".Background: sessile serrated lesions (ssls) are more prone to incomplete resection than conventional adenomas.This study evaluated whether circumferential submucosal incision prior to endoscopic mucosal resection (csi-emr) can increase the rate of complete and en bloc resections of colorectal lesions with endoscopic features of ssl.Methods retrospective analyses and propensity score matching were performed for the resection of colorectal lesions=10 mm with endoscopic features of ssl.Results after 1:1 ratio matching, 127 lesions in the csi-emr group and 127 in the emr group were selected for analysis.The median size of the lesions was 15 mm (iqr 12¿16) in both groups.There was no signifcant diference in either the complete resection rate or en bloc resection rate between csi-emr and emr groups (96.9% vs.92.9%, p=0.155; 92.1% vs.89.0%, p=0.391).By contrast, the r0 resection rate was signifcantly higher in the csi-emr group than in the emr group (89.8% vs.59.8%, p<0.001).The median procedure time was signifcantly longer in the csi-emr group than in the emr group (6.28 min vs.2.55 min, p<0.001), whereas there was no signifcant diference between the two groups in the incidence of adverse events or recurrence rate.Multivariate analysis showed that csi-emr was the only factor signifcantly associated with r0 resection (p<0.001).Conclusions for colorectal lesions with endoscopic features of ssl, csi-emr does not increase the complete or en bloc resection rate, but does increase the r0 resection rate.The procedure time is longer for csi-emr than emr.The association of csi-emr with r0 resection and non-recurrence should be further evaluated.Type of adverse events/number of patients [circumferential submucosal incision prior to endoscopic mucosal resection (csi-emr)] immediate bleeding - 8 patients.Delayed bleeding - 1 patient.Perforation - 1 patient.[endoscopic mucosal resection (emr)] immediate bleeding - 3 patients.Delayed bleeding - 2 patients.Recurrence - 1 patient.This literature article requires 6 reports.The related patient identifiers are as follows: 1.(b)(6) (model number : cf-hq290i): the current case 2.(b)(6) (model number : cf-h260ai).3.(b)(6) (model number : sd-210l-25).4.(b)(6) (model number : kd-650q).5.(b)(6) (model number : kd-655q).6.(b)(6) (model number : kd-v441m).This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

No device was returned to olympus.A device history record review could not be performed due to no serial/lot number available.A root cause of the reported event could not be determined.A device malfunction has not been reported, and from clinical/medical evaluation and risk assessment, it is presumed that the reported event is an accident or a complication associated with a surgical procedure using the subject device.The literature article is attached to this report.

• Brand Name: DISPOSABLE ELECTROSURGICAL SNARE
• Type of Device: DISPOSABLE ELECTROSURGICAL SNARE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16865572
• MDR Text Key: 314526379
• Report Number: 9614641-2023-00602
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SD-210L-25
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2023
• 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
• Patient Outcome(s): Other