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

Model Number	KD-620LR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Chest Pain (1776); Fever (1858); Hemorrhage/Blood Loss/Bleeding (1888); High White Blood Cell Count (4594)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to the following linked patient identifiers: (b)(6).The device was not returned.Attempts were performed to obtain additional information, but no response was received.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
Olympus reviewed the following literature titled "association of local steroid injection as a risk factor for electrocoagulation syndrome after esophageal endoscopic submucosal dissection." this study aimed to investigate the risk factors associated with post-endoscopic submucosal dissection electrocoagulation syndrome (peecs) in patients undergoing esophageal endoscopic submucosal dissection (esd), focusing on the significance of local steroid injections.In a total of 202 consecutive patients, peecs was recorded in 98 patients.Patients with peecs exhibited a larger tumor size (25.0 vs.17.0 mm, p=0.002), longer procedure (40.0 vs.29.5 min, p=0.021) and hemostasis times (5.0 vs.3.5 min, p=0.004), required greater submucosal injection volume (60.0 ml vs.50.0 ml, p=0.030), and had a lower rate of local steroid injection (4.1% vs.12.5%, p=0.029) than those without peecs.Type of adverse events/number of patients post-endoscopic submucosal dissection electrocoagulation syndrome (peecs) (98 patients) (include as follows): fever (91 patients) leukocytosis (91 patients) chest pain (82 patients) delayed bleeding (3 patients) extended-spectrum--lactamase negative escherichia coli positive blood culture (1 patient) esophageal peecs was defined by satisfying at least two of the following criteria: fever =37.8° c, leukocytosis = 10,800/mm3, and localized chest pain = 5/10 points as associated on a numeric rating scale within 24 hours after esd.Among the 98 patients with peecs, 93 (94.9%) were administered empirical antibiotics after blood and culture tests.In one patient, the blood culture was positive for extended-spectrum--lactamase negative escherichia coli.The patient was treated with intravenous antibiotics without complications.Similarly, in this study, only delayed bleeding was observed in three (1.5%) patients.Treatment/intervention information for delayed bleeding was not provided in the literature.
Event or Problem Description
The author was asked for additional information, but all requested details were unavailable.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide additional information provided by the author (b5).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 events 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
• 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: 20065515
• Report Number: 9614641-2024-01711
• Device Sequence Number: 8826059
• Product Code: KNS
• UDI-Device Identifier: 04953170453946
• UDI-Public: 04953170453946
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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-620LR
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: D-201-11804 DISPOSABLE DISTAL ATTACHMENT; GIF-H260 EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE; GIF-HQ290 EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE; KD-611L SINGLE USE ELECTROSURGICAL KNIFE; KD-655L SINGLE USE ELECTROSURGICAL KNIFE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown