MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. PRECUTTING KNIFE; PRE-CUTTING KNIFE

Model Number	KD-10Q-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	09/14/2022
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 reviewed the following literature titled "underwater endoscopic submucosal dissection and hybrid endoscopic submucosal dissection as rescue therapy in difficult colorectal cases".This retrospective analysis demonstrates that underwater esd (u-esd) and hybrid esd (h-esd) are both effective and safe as rescue therapy in difficult colorectal esd.There were fifty-nine colorectal neoplasms were considered, 22 of which were removed by u-esd and 37 by h-esd.The en bloc resection rate in the u-esd group was 100 %, while it was 59.5% in the h-esd group.Dissection speed was 17.7mm2/min in the u-esd group and 8.3mm2/min in the h-esd group.This study concludes that the u-esd and h-esd are both effective and safe techniques in difficult colorectal situations.U-esd is particularly effective and fast for large lesions when it is not possible to obtain comfortable knife position, while h-esd is more suitable for very fibrotic lesions.Type of adverse events/number of patients: [underwater esd] bacteremia - 1 patient.[hybrid esd].Perforation - 4 patients.Bleeding - 4 patients.Bacteremia - 1 patient.This literature article requires 4 reports.The related patient identifiers are as follows: (b)(6) (kd-10q-1).(b)(6) (kd-650l: for single use electrosurgical knife).(b)(6) (sd-210l-10: snare master).(b)(6) (fd-210u: for hot biopsy).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
This supplemental report is being submitted to provided additional information from the author (see b5).
Event or Problem Description
In the medical opinion of the author, the olympus device did not cause malfunction nor the adverse events reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or 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.Therefore, the root cause cannot be determined.This supplemental report includes a correction to e4 and g2.Information added that was inadvertently not included on previous submissions.Olympus will continue to monitor field performance for this device.

• Brand Name: PRECUTTING KNIFE
• Common Device Name: PRE-CUTTING 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: 16088677
• Report Number: 9614641-2023-00004
• Device Sequence Number: 16649302
• Product Code: KNS
• UDI-Device Identifier: 04953170038051
• UDI-Public: 04953170038051
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K955247
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2023

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-10Q-1
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 01/13/2023; 01/16/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 01/13/2023; 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown