MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-612

Model Number	KD-612L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
Olympus medical systems corp.(omsc) reviewed a literature titled "ingenuity of colorectal esd in patients with folds and poor operability and closure method using sb clips for mucosal defects after esd." purpose: colorectal esd for lesions on folds is generally difficult, but in patients with poor operability, the difficulty increases and the perforation rate increases.By fixing the blade part on the fold and twisting the scope, the it knife nano can be peeled off by controlling the knife in the direction away from the muscle layer.Examined gender.In addition, the suturing method is important for ensuring safety in high-difficulty cases.Study (1) among 1360 cases of colorectal esd performed at our hospital, 82 cases with lesions on folds that were difficult to operate were treated with it(+) group using it knife nano in combination with 49 cases.Thirty-three patients were classified into the it(1) group, which was not used in combination, and the clinicopathological background and treatment results of the two groups were compared.Study (2) 95 consecutive colorectal esd cases performed after march 2020 were divided into group a (sb clip) and group b (conventional clip) by the minimization method using localization, tumor size, and operability as allocation adjustment factors.They were randomly assigned to 2 groups, and the rate of complete closure of mucosal defects after esd was compared.Study (1) the clinicopathological background of it(+) group vs it(1) group was as follows: average tumor diameter (mm): 34 vs 31, tumor morphology (lst-g/lst-ng/polypoid): 17/28/4 vs 12/19/2, histopathological results (adenoma/tis/tla/tlb): 14/29/1/5 vs 5/25/1/2, showing a significant difference between the two groups.I didn't approve.Treatment results were average treatment time (min): 68 vs 78, en bloc resection rate: 100% vs 88% (p<0.05), complete en bloc resection rate: 96% vs 85% (p<0.05), perforation rate: 4%.The rate of en bloc resection and complete en bloc resection was significantly higher in the it(+) group than in the it(1) group.Study 2) the complete suturing rate was 100% in group a and 92% in group b with a resection diameter of less than 30 mm, and no significant difference was observed.% and significantly higher in group a (p<0.05).In addition, 92% of the unsuccessful cases of complete suture in group b were able to suture completely after changing the sb clip, and complete suturing was possible even for resection diameters up to 75 mm.[conclusion] the it knife nano is useful for cases with poor operability due to presence on folds, and the sb clip was able to completely suture a large mucosal defect compared to conventional clips.Type of adverse events/number of patients: perforation -4%.The literature described "it knife nano", "kd-612l" was selected as a representative product since it was shipped the most in the area and in the study period.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information obtained from the customer and the results of the legal manufacturer's final investigation.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.
Event or Problem Description
The user provided additional information regarding the event: 1.The user was unable to provide any serial or lot numbers for the olympus devices used in the article.2.The user stated the olympus devices did not cause or contribute to the adverse events reported in the article.The complications were due to procedural factors, and were not caused by the patient's underlying disease or condition or by non-olympus products.3.The olympus device is not available for return.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-612
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15779096
• Report Number: 9614641-2022-00602
• Device Sequence Number: 6620057
• Product Code: KNS
• UDI-Device Identifier: 04953170325892
• UDI-Public: 04953170325892
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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-612L
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 11/29/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown