MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-625

Model Number	KD-625LR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Stenosis (2263)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled "endoscopic dilation for stenosis after esophageal endoscopic submucosal dissection: knack and pitfalls".When a post-resection ulcer is expected to involve more than three-fourths of the esophageal circumference, it is advisable to consider preventive measures against stenosis, such as submucosal triamcinolone injection, as such lesions are associated with a high risk of stenosis following endoscopic resection.In the case of stricture development, endoscopic balloon dilation (ebd) is performed.To prevent perforation during ebd, it is recommended to use a 12-15 mm balloon and gradually increase the pressure to 8 atm over 4 min.For severe stenosis, a 10-12mm balloon is used.In the event of a perforation during ebd, fasting and administrating antibiotics are necesssary.If conservative treatment fails to show any improvement, surgical drainage should be considered.Type of adverse events/number of patients postoperative stenosis- 3 patients, perforation- 1 patient.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6) : kd-625lr.(b)(6) : gif-h290t.There is no report of any olympus device malfunction in any procedure described in this study.
Additional Manufacturer Narrative
Since the literature described "hook knife j" we selected ¿kd-625lr¿ as a representative product.The suspect device has not been returned to olympus for evaluation.The investigation is in process.*the literature article is attached for additional information.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.This supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-625
• 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: 18379429
• Report Number: 9614641-2023-01984
• Device Sequence Number: 7712758
• Product Code: KNS
• UDI-Device Identifier: 04953170407826
• UDI-Public: 04953170407826
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K182408
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

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-625LR
• 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: 12/07/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/23/2024
• 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