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

Model Number	KD-650L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pneumoperitoneum (4819)
Date of Event	12/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "endoscopic resection for gastric submucosal tumors: japanese multicenter retrospective study (with a video)." the study was to elucidate the current scenario of endoscopic resection (er) for gastric submucosal tumors (smts) in japanese endoscopic practice.Patients (from 12 institutions) with gastric smts who underwent er were enrolled from the first case until august 2020.There was 117 patients with 118 lesions enrolled in the study.The number of patients who underwent er increased over the years.According to the japanese guidelines for the treatment of gastrointestinal stromal tumors (gists) the following are indicated for resection: 1) histologically diagnosed as gist 2) >5 cm 3) tendency to enlarge 4) malignant findings.It knife, it knife 2, or it knife nano (kd-610l, kd-611l, or kd-612, olympus, tokyo, japan) and needle scalpels were used in 71 cases (61%).Adverse events: two patients had postoperative bleeding that was stopped endoscopically one of them required blood transfusion.Three lesions required conversions to laparoscopic surgery due to luminal collapse, uncontrolled bleeding, and difficulty in defect closure.Pneumoperitoneum occurred in 21 patients (21%).No adverse events requiring surgical intervention were observed.The survival and recurrence status as of august 31, 2021 was confirmed in 112 patients (96%).Five patients were unknown whether alive or dead, and three patients died of other diseases (heart failure after 1.7 years, gastric cancer death after 5.6 years, and pneumonia after 7.9 years).This report is related to patient identifiers: (b)(6).
Additional Manufacturer Narrative
Since the literature described "dualknife(table 2)", we selected "kd-650l" as a representative product for processing purposes.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.
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.

• 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 (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: 18660263
• Report Number: 9614641-2024-00303
• Device Sequence Number: 12544976
• Product Code: KNS
• UDI-Device Identifier: 04953170265761
• UDI-Public: 04953170265761
• 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): 02/28/2024

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-650L
• 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: 01/11/2024
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 02/28/2024
• 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: Required Intervention
• Patient Sex: Unknown