MAUDE Adverse Event Report: AIZU 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 Codes	Abdominal Pain (1685); Fever (1858); Hemorrhage/Bleeding (1888); Perforation (2001)
Date of Event	05/15/2022
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.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: "laparoscopy-assisted transgastric endoscopic retrograde cholangiopancreatography in bariatric roux-en-y gastric bypass patients." literature summary: objectives: endoscopic submucosal dissection (esd) of colorectal lesions was invented in japan, but postoperative management including hospital stay has not been reconsidered due to the japanese insurance system.To explore appropriate postoperative management after colorectal esd, we reviewed short-term outcomes after esd in non-selected consecutive patients.Methods: patients who underwent colorectal esd from april 2013 to september 2020 in one institution were reviewed.The primary outcome measure was the occurrence of adverse events stratified by the clavien-dindo classification with five grades.A logistic regression model with the firth procedure was applied to investigate predictors of severe (grade iii or greater) adverse events.Results: a total of 330 patients (female 40%, male 60%; median 72 years; iqr 65¿80 years) with colorectal lesions (median 30 mm, iqr 23¿40 mm; colon 77%, rectum 23%; serrated lesion 4%, adenoma 47%, mucosal cancer 30%, invasive cancer 18%) was evaluated.The en bloc resection rate was 97%.The median dissection time was 58 min (iqr: 38¿86).Intraprocedural perforation occurred in 3%, all successfully treated by endoscopic clipping.No delayed perforations occurred.Postprocedural bleeding occurred in 3% on days 1¿10 (median day 2); all were controlled endoscopically.Severe adverse events included only delayed bleeding.In analyzing severe adverse events in a multivariate logistic regression model with the firth procedure, antithrombotic agent use (p = 0.016) and rectal lesions (p = 0.0010) were both significant predictors.Conclusions: no serious adverse events occurred in this series.Four days of hospitalization may be too long for the majority of patients after esd.Type of adverse events/number of patients: intra-procedural perforation n=10.Fever n = 20.Abdominal pain n = 30.Delayed bleeding n = 9.
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.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Follow up was conducted with the author of the clinical literature article, and the following additional information was received: there were no problems caused by an olympus device regarding any of the events described in the article.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-650
• Common Device Name: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15212092
• Report Number: 9614641-2022-00132
• Device Sequence Number: 18592983
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2022

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: 07/14/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 09/19/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NON-OLYMPUS DEVICES: COLONOSCOPE, SHORT-TYPE HOOD,; NON-OLYMPUS DEVICES: INSUFFLATOR, FLUSHKNIFE,; NON-OLYMPUS: HIGH-FREQUENCY GENERATOR
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown