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); Unspecified Infection (1930); Internal Organ Perforation (1987)
Date of Event	06/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the literature described "risk factors for postoperative complications in endoscopic resection of gastric gastrointestinal stromal tumors: a multi-center analysis", olympus selected gif-q260j as a representative product.The suspect device was not returned to olympus for evaluation.Since the serial number is unknown, a review of the dhr could not be performed.Based on the results of the investigation, the root causes of the events could not be determined; however, the event is an accident or a complication associated with a surgical procedure using the subject device.In addition, the events occurred after the doctor considered the clinical risk of the surgical procedure.The malfunction of the device has not been reported; therefore, the use of the subject device for this application is not restricted.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
Olympus reviewed the following literature titled " "risk factors for postoperative complications in endoscopic resection of gastric gastrointestinal stromal tumors: a multi-center analysis." this retrospective study aimed to determine factors associated with postoperative complications for endoscopic resection (er) of gastric gastrointestinal stromal tumors (ggists).A total of 513 cases were finally analyzed.Multivariate logistic regression analysis showed that long operative time (or=50.655, p<0.001) and severe intraoperative bleeding (or=4.731, p=0.032) were independent risk factors for delayed bleeding.Significant differences were found in tumor size, invasion depth, procedure time, and intraoperative complication (severe intraoperative bleeding and perforation) (p<0.05).Multivariate logistic regression analysis showed that long operative time (or=13.749, p<0.001) and perforation (or=4.339, p<0.001) were independent risk factors for postoperative infection.In conclusion, the study indicated the risk factors for postoperative complications in er of ggists.Long operation time is a common risk factor for delayed bleeding and postoperative infection.Patients with these risk factors should be given careful observation postoperatively.Type of adverse events/number of patients: delayed bleeding- 27 patients, postoperative infection- 69 patients, severe intraoperative bleeding- 16 patients, delayed perforation- 1 patient, conversion- 12 patients.One patient needed a blood transfusion due to delayed bleeding.Hemostasis was successfully achieved in 3 patients with drug therapy.Twenty-four patients were successfully stanched by metal clipping (5 cases), argon plasma coagulation (5 cases), and hot biopsy forceps (14 cases) under emergency endoscopy.The delayed perforation was successfully cured by supportive nutritional therapy with nasogastric decompression.In the postoperative infection group, 34 patients had only fever without increased inflammatory index, and no antibiotic treatment was given; 35 patients had fever with increased inflammatory index and were cured after antibiotic treatment.This literature article requires 3 reports.The related patient identifiers are as follows: (b)(6): gif-q260j, (b)(6): kd-650l, (b)(6): kd-611l.This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18023193
• Report Number: 9614641-2023-01601
• Device Sequence Number: 20722089
• Product Code: KNS
• UDI-Device Identifier: 04953170265761
• UDI-Public: 04953170265761
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/27/2023

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
• 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: 10/02/2023
• Initial Report FDA Received Date: 10/27/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown