MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. ELECTROSURGICAL KNIFE; PAPILLOTOMY KNIFE

Model Number	KD-31C-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Hemoptysis (1887); Hemorrhage/Blood Loss/Bleeding (1888); Pneumothorax (2012)
Date of Event	10/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled "transbronchial needle aspiration combined with cryobiopsy in the diagnosis of mediastinal diseases: a multicentre, open-label, randomised trial.¿ this prospective study aimed to evaluate the efficacy and safety of combined application of endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna) and mediastinal cryobiopsy versus ebus-tbna alone for the diagnosis of mediastinal diseases.A total of 271 patients were randomly assigned to receive either ebus-tbna plus transbronchial mediastinal cryobiopsy (combined group; n=136) or ebus-tbna alone (control group; n=135; figure).Sequential application of ebus-tbna and trans bronchial mediastinal cryobiopsy led to a significant increase in the overall diagnostic yield compared with ebus-tbna alone (126 [93%] of 136 participants in the combined group vs 109 [81%] of 135 in the control group.Whereas the combined biopsy was more sensitive than ebus-tbna alone in benign diseases (45 [94%] of 48 vs 28 [64%] of 44, rr 1·47 [95% ci 1·17¿1·86]; p=0·0004.The overall diagnostic yield of 82% (110 of 134 participants) for ebus-tbna and 91% (122 of 134) for cryobiopsy (rr 1·11 [95% ci 1·01¿1·22]; p=0·032).In conclusion, cryobiopsy proved safe and led to a significant gain in overall diagnostic yield compared with ebus-tbna alone.Types of adverse events and number of patients involving the ultrasonic bronchofibervideoscope are as follows: bleeding (grade 3) - 5 patients bleeding (grade 2) - 30 patients coughing - 31 patients dyspnoea - 6 patients haemoptysis - 5 patients pneumothorax - 6 patients pneumomediastinum -1 patient minor bleeding (grade 2) subsided without the need for intervention.The incidence of pneumothorax and pneumomediastinum were detected by chest radiography, although none of these required drainage or other treatment.No serious adverse events were reported during the procedure or at the 4 week follow up.Types of adverse events and number of patients involving the electrosurgical knife are as follows: bleeding (grade 2) - 16 patients bleeding (grade 3) ¿ 3 patients coughing - 19 patients dyspnoea - 2 patients haemoptysis - 3 patients pneumothorax - 6 patients pneumomediastinum -1 patient this literature article requires 2 reports.The related patient identifiers are as follows: (b)(6) / (b)(6)/ (b)(6) 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.
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The literature article is attached for additional information https://doi.Org/10.1016/ s2213-2600(22)00392-7.As the lot number/manufacturing number of the device used is unknown and was not provided, the device history record cannot be investigated.However, olympus conducts inspections and only ships products that pass the inspections.Based on the information available, it is not possible to identify the root cause of the reported event.However, it is likely the reported event is an accident, or a complication associated with a surgical procedure using the subject device.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.The suspect device has not been returned to olympus for evaluation.Olympus will continue to monitor the field performance of this device.

• Brand Name: ELECTROSURGICAL KNIFE
• Common Device Name: PAPILLOTOMY 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: 17304734
• Report Number: 9614641-2023-00972
• Device Sequence Number: 7158021
• Product Code: FAJ
• UDI-Device Identifier: 04953170049323
• UDI-Public: 04953170049323
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K993041
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/12/2023

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-31C-1
• 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: 06/13/2023
• Initial Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NON-OLYMPUS NEEDLE-KNIFE (20402-401).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown