MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. PRECUTTING KNIFE; PRE-CUTTING KNIFE

Model Number	KD-10Q-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypoxia (1918); Perforation (2001); Pancreatitis (4481)
Date of Event	07/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled, "balloon enteroscopy-assisted endoscopic retrograde cholangiopancreatography for the treatment of common bile duct stones in patients with roux-en-y gastrectomy: outcomes and factors affecting complete stone extraction." this retrospective study investigated the treatment outcomes and potential factors affecting complete stone extraction in 79 patients.The initial success rates of reaching the papilla of vater, biliary cannulation, and biliary intervention, including complete stone extraction or biliary stent placement, were 92%, 81%, and 78%, respectively.The multivariate analysis indicated that the largest cbd diameter = 14 mm (odds ratio (or), 0.04; 95% confidence interval (ci), 0.01¿0.58) and retroflex position (or, 6.43; 95% ci, 1.12¿36.81) were independent predictive factors affecting complete stone extraction achievement.This study concludes that therapeutic sdbe-ercp for cbd stones in a relatively elderly ryg cohort, was effective and safe.Type of adverse events/number of patients.Mild perforation - 1 patient.Moderate perforation - 1 patient.Mild pancreatitis - 1 patient.Mild hypoxia - 1 patient.This was a multi-center retrospective study conducted in three tertiary hospitals.This literature article requires 8 reports.The related patient identifiers are as follows: (b)(6)/pr-v220q/ae.(b)(6)/kd-10q-1/ae.(b)(6)/fg-v425pr/ae.(b)(6)/bml-v437qr-30/ae.(b)(6)/pr-v220q/hypoxia for 83-year-old.(b)(6)/kd-10q-1/hypoxia for 83-year-old.(b)(6)/fg-v425pr/hypoxia for 83-year-old.(b)(6)/bml-v437qr-30/hypoxia for 83-year-old.This medwatch 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 investigation is in process.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 d8 and g2 to provide information that was inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: PRECUTTING KNIFE
• Common Device Name: PRE-CUTTING 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: 16127835
• Report Number: 9614641-2023-00017
• Device Sequence Number: 3238294
• Product Code: KNS
• UDI-Device Identifier: 04953170038051
• UDI-Public: 04953170038051
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955247
• 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,Followup
• Report Date (Section B): 01/20/2023

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-10Q-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: 12/11/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 01/20/2023
• 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: ENTEROSCOPE (EI-530B OR EI-580BT); NON-OLYMPUS: SPHINCTEROTOME (ROTACUTII)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown