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

Model Number	KD-610L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001); Stenosis of the esophagus (4487)
Date of Event	08/03/2021
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 titled "long-term outcomes of endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma in taiwan." the study is to evaluate the long-term outcomes of endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma in taiwan.Total of 229 lesions in 162 patients were enrolled.Forty-nine subjects developed complications, including six (2.6%) with major bleeding, two (0.9%) with perforation, and 41 (17.9%) with strictures.Pathological staging showed that 19 cases had deep submucosal cancer invasion and subsequently received adjuvant therapies.During a mean follow-up period of 52.6 (range 3¿146) months, 41 patients developed metachronous recurrence.The patients with a type c-d lugol staining back-ground pattern were associated with a higher risk of recurrence than those with few lvls.The 10-year survival rate was more than 90%, and only eight patients died of escc.Esd has excellent long-term outcomes but a high risk of metachronous recurrence.The lugol staining pattern over the background mucosa could offer the risk stratification of metachronous recurrence.Type of adverse events/number of patients: massive bleeding during esd - 2 patient.Delayed bleeding - 4 patients.Perforation during esd - 2 patients.Post-esd esophageal strictures - 41 patients.Died of escc - 8 patients.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6) :kd-610l, (b)(6) :fd-410lr.This medwatch report is for patient identifier (b)(6).The deaths were determined to be not reportable.There is no report of any olympus device malfunction in any procedure described in this study.
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.This supplemental report includes information added to g2.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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15092786
• Report Number: 9614641-2022-00026
• Device Sequence Number: 4814076
• Product Code: KNS
• UDI-Device Identifier: 04953170208546
• UDI-Public: 04953170208546
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022

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-610L
• 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: 06/27/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 09/09/2022
• 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: FD-410LR, LOT UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown