MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-650

Model Number	KD-650Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/15/2022
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.The literature article is attached for additional information.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 "comparison of endoscopic submucosal resection with ligation and endoscopic submucosal dissection for small rectal neuroendocrine tumors: a multicenter retrospective study".Literature summary objectives: endoscopic submucosal resection with band ligation (esmr-l) and endoscopic submucosal dissection (esd) are both standard endoscopic resection methods for rectal neuroendocrine tumors (nets) <10 mm in size.However, there is no definitive consensus on which is better.Here, we compared the efficacy of esmr-l and esd for small rectal nets.Methods: this was a multicenter retrospective cohort study including 205 patients with rectal nets who underwent esmr-l or esd.Treatment outcomes were compared by univariate analysis, multivariate analysis, and inverse probability treatment weighting (iptw) using propensity scores.Subgroup analysis evaluated the impact of the endoscopist's experience on the technical outcome.Results: eighty-nine patients were treated by esmr-l and 116 by esd.The ro resection rate was not significantly different between the two (90% vs.92%, p = 0.73).The procedure time of esmr-l was significantly shorter than for esd (17 min vs.52 min, p < 0.01) and the hospitalization period was also significantly shorter (3 days vs.5 days, p < 0.01).These results were confirmed by multivariate analysis and also after iptw adjustment.The procedure time of esd was significantly prolonged by a less-experienced endoscopist (49 min vs.70 min, p = 0.02), but that of esmr-l was not affected(17 min vs.17 min, p = 0.27).Conclusions: for small rectal nets, both esmr-l and esd showed similar high complete resection rates.However, considering the shorter procedure time and shorter hospitalization period, esmr-l is the more efficient treatment method, especially for less-experienced endoscopists.Type of adverse events/number of patients: delayed bleeding(esd method) -2 postoperative bleeding was defined as the presence of fresh bloody stool, which required urgent endoscopy for hemostasis.All cases of postoperative bleeding were successfully managed with endoscopic hemostasis, and no blood transfusion or surgery was required.
Event or Problem Description
The author confirmed the olympus device did not cause or contribute to any of the patient adverse events.The olympus device did not malfunction during any procedure.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information received from the authoring physician and the legal manufacturer's final investigation.B5: updated with information received from the authoring physician.The device history record was unable to be reviewed for this device since the serial 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 is no evidence of an olympus device malfunction.The root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-650
• 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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15777131
• Report Number: 9614641-2022-00593
• Device Sequence Number: 4897445
• Product Code: KNS
• UDI-Device Identifier: 04953170265778
• UDI-Public: 04953170265778
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2022

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-650Q
• 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: 10/13/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 11/28/2022
• 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