MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-650

Model Number	KD-650Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	04/28/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Since the literature described "dualknife, dualknifej, or needle knife", "kd-650q", "kd-655q", and "kd-v441m" were selected as representative devices, respectively.The suspect device has not been returned to olympus for evaluation.The investigation was completed based on the current information available.A dhr could not be reviewed since the serial number was unknown.It was not possible to identify the root cause of the reported event.In addition, the malfunction of the device 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 for additional information.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-650
• Common Device Name: SINGLE USE ELECTROSURGICAL KNIFE
• 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: 16865613
• Report Number: 9614641-2023-00603
• Device Sequence Number: 5385391
• Product Code: KNS
• UDI-Device Identifier: 04953170265778
• UDI-Public: 04953170265778
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K092309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: KD-650Q
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown