MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-655

Model Number	KD-655Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	01/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing, this report will be supplemented when new and relevant information becomes available.
Event or Problem Description
Olympus reviewed the following literature titled "v3-1 utility and safety of tech knife in colorectal esd." literature summary endoscopic submucosal dissection (esd) of colorectal tumors is considered a technically difficult and time-consuming procedure.It has been reported that advances in devices contribute to a reduction in the complication rate, and various devices have been developed to date to improve the safety and efficiency of the procedure.Unlike conventional tip-based knives, the tecknife (microtec, inc.) can deliver fluid from the tip of the knife, enabling efficient incision and dissection, which may result in a reduction in esd procedure time.Objective to prospectively evaluate the efficacy and safety of the microtec knife in colorectal esd.Methods (b)(4) colorectal esd cases performed during a 6-month period from (b)(6) 2023 were divided into 2 groups: tk group ((b)(4) cases) using a techknife and dk group ((b)(4) cases) using dualknife j (olympus), and compared.The primary endpoint was dissection speed, and secondary endpoints were esd procedure time, the number of times the local injection needle was inserted and removed, total local injection volume, and intraoperative perforation rate.The authors also performed a subgroup analysis by dividing the patients into two groups: experts with more than (b)(4) esd cases and non-experts with less than (b)(4) esd cases.Results there were no significant differences in patient background (age, gender, comorbidities, anticoagulant medications, localization, gross type, expert / nom-expert) between the two groups.Clinicopathologically, the two groups did not differ in resection specimen diameter (36.5 mm vs 33.6 mm; p=0.22), tumor diameter (30.8 mm vs 27.7 mm; p=0.18), pathologic findings (adenoma/serrated lesion/cancer 36/15/18 vs 27/16/25; p=0.31), and ro resection rate (97.1% vs 94.1%; p=0.12).Although there was no significant difference between the two groups in terms of total localized volume (34.3 ml vs.32.7 mm; p=0.67), the number of device insertions and removals was significantly lower in the tk group than in the dk group (2 vs.3.5 times: p<0.05), resulting in a trend toward faster procedure times in the tk group (42.7 min vs 52.5 min; p=0.13) and significantly faster dissection speed (36.2 mm2 vs 23.4 mm2: p<0.05).Device occlusion was observed in 3 patients (43%) in the tk group, but not in the dk group.Intraoperative perforation occurred in 2 patients (2.9%) in the dk group, but not significantly (p=051).The results of the expert/non-expert group were also compared with those of the tk and dk groups, respectively.Experts in the tk group had significantly fewer device insertions and removals (2 vs.3.6 times; p<0.05), shorter esd procedure times (37.5 min vs 50.3 min; p=0.07), and significantly faster dissection speeds (36.8 mm2 vs 26.5 mm2; p<0.05).On the other hand, there was no difference in any of the parameters between the tk and dk groups in the non-expert group.Conclusion compared to the dualknife j, the techknife may reduce procedure time by reducing the number of times the device is inserted and removed, and by performing dissection more efficiently, suggesting that the use of the techknife may be more effective, especially for experts.Type of adverse events/number of patients intraoperative perforation (n=2).
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 additional information received from the author.B5 updated accordingly.Olympus will continue to monitor field performance for this device.
Event or Problem Description
An olympus device did not cause or contribute to the adverse events described in the article.Also, it was confirmed that an olympus device malfunction did not occur.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-655
• 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: 18868702
• Report Number: 9614641-2024-00627
• Device Sequence Number: 15437752
• Product Code: KNS
• UDI-Device Identifier: 04953170405631
• UDI-Public: 04953170405631
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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-655Q
• 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: 02/14/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 03/14/2024
• 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: Other
• Patient Sex: Unknown