MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-655; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	KD-655U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Hemorrhage/Bleeding (1888); Pain (1994); Stenosis of the esophagus (4487)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation and the investigation is in process.For more information, the literature article can be found at: doi: 10.1002/deo2.81.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: single operator experience of endoscopic submucosal dissection for barrett's neoplasia in a north american academic center by douglas motomura robert bechara.Abstract: objectives: endoscopic submucosal dissection (esd) is carving out an increasing role in the treatment of barrett's associated neoplasia.Esd provides the advantage of en-bloc resections and greater ro resection rates.We aim to present outcomes from one of the largest single-center cohorts of esophageal esd in north america.Methods: all patients undergoing esophageal esd for barrett's neoplasia between oct 2016 and june 2020 at a canadian tertiary care center were included.Demographic, procedural data, and lesion characteristics are presented.Subgroup analysis was performed on patients who underwent extensive resection (>75% of esophageal circumference) and the patients who developed strictures.Results: thirty-four patients were included in the series.The median lesion diameter was 5.7 cm and the median procedure time was 129 min.The enbloc resection rate was 97%, and the ro resection rate was 91%.Curative resection was achieved in 82% of patients.Upstaging in histology occurred in 59% of cases.Two adverse events occurred, and there were no perforations.Procedural outcomes were similar in patients with extensive resections, but those with >75% circumferential resection developed more strictures (65% vs.6.3%, p < 0.01).Stricture formation was associated with extensive resection (odds ratio [or]: 27.5, p < 0.01) and longer lesion diameter (or: 1.7, p = 0.02).Conclusion: our experience with esd for barrett's related neoplasia shows excellent en-bloc and ro resection rate, and provides more accurate histological specimens.Curative resection is possible in the majority of cases, including those with extensive resections.Further investigation into stricture prophylaxis will be useful as near circumferential resections are attempted.The following adverse events were reported involving dualknife kd-650 or dualknife j kd-655: n = 1: one case was aborted due to encountering multiple varices.N = 1: aspiration - one patient had an aspiration event on extubation in the operating room care and required re-intubation.N = 1: delayed bleeding - the second patient developed bleeding after discharge and returned on post-procedure day 4.Conservative management was sufficient, and no-repeat endoscopy or blood transfusions were required.N = 12: stricture formation in patients who had extensive resections; dilations at follow up endoscopies; a median of three balloon dilations were required in patients who developed strictures.Unknown number of patients: admitted for post-operative pain control.The authors did not specify which patients involved which olympus device.There are two reports involved with this literature as follows: (b)(6) dualknife kd-650, (b)(6) dualknife j kd-655.This is report 2 of 2 for - (b)(6) dualknife j kd-655.
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 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: SINGLE USE ELECTROSURGICAL KNIFE KD-655
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• 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: 13516243
• Report Number: 8010047-2022-02832
• Device Sequence Number: 15935659
• Product Code: KNS
• UDI-Device Identifier: 04953170377532
• UDI-Public: 04953170377532
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K171158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2022

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-655U
• 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: 01/13/2022
• Supplement Date Received by Manufacturer: 03/23/2022; 06/10/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 04/19/2022; 07/06/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown