MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ELECTROSURGICAL KNIFE

Model Number	KD-1L-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature: "randomized study of two endo-knives for the traction-assisted endoscopic submucosal dissection of early esophageal squamous cell carcinoma" by yoshiyasu kitagawa, et al.Abstract: needle-type devices, such as the dualknife (olympus, tokyo, japan), are widely used for traction-assisted esophageal endoscopic submucosal dissection (esd) but require a prolonged operation time.An improved model of the itknife (olympus), the itknife nano, may allow faster and easier esd than the dualknife.We conducted a randomized study to compare the performances of the dualknife and the itknife nano for traction-assisted esophageal esd.Patients with early esophageal squamous cell carcinoma were eligible for this study.The primary outcome was the total procedure time.The secondary outcomes were submucosal dissection time, en bloc, and complete resection rates, perforation rate, and adverse events.Results fifty patients were equally divided into two groups: the dualknife group (d-group) and the itknife nano group (i-group), and all underwent the assigned treatment.The i-group had significantly shorter total procedure time (36.8 vs.60.7 min; p0.01) and submucosal dissection time (17.2 vs.35.8 min; p0.01) than the d-group.The en bloc and complete resection rates were sufficiently high in both groups (100% and 100% in the d-group and 100% and 96% in the i-group, respectively).Significantly fewer hemostatic procedures due to intraoperative bleeding were performed in the i-group than in the d-group (0.2 vs.1.4; p¿<¿0.01).Delayed bleeding, perforation, or esophageal stricture did not occur in either group.The itknife nano exhibited lower procedure time for traction-assisted esophageal esd than the dualknife, without increasing adverse events.Adverse events: muscular layer exposure, n=7.The authors reporting using six (6) olympus devices during the study.This article includes 6 reports: (b)(6): kd-650l(dualknife as the representative product), (b)(6): gif-q260j, (b)(6): c22135343: gif-h290t, (b)(6): d-201-11804, (b)(6): kd-1l-1, (b)(6): fd-410lr.This is report 5 of 6:(b)(6): kd-1l-1.
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
Additional information was provided by the author: in the opinion of the author, there was not a relationship between the olympus device and muscle layer exposure.The author reported no medical intervention was required.In addition, the authors defined muscle layer exposure as: when the fine texture of the muscle fibers of muscularis propria was clearly exposed and visible endoscopically, due to deep submucosal dissection.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the author and the legal manufacturer's investigation.New information added to the following fields: b5, h6, h10.B1: no change in reportability.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.

• Brand Name: ELECTROSURGICAL KNIFE
• Common Device Name: ELECTROSURGICAL KNIFE
• 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: 14170770
• Report Number: 8010047-2022-06804
• Device Sequence Number: 20086612
• Product Code: KGE
• UDI-Device Identifier: 04953170037702
• UDI-Public: 04953170037702
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062517
• 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
• Report Date (Section B): 06/09/2022

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-1L-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: 03/23/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 06/09/2022
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LOT:D-201-11804,KD-650L,FD-410LR.; UNKNOWN SERIAL: (B)(6).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown