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	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)
Date of Event	06/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature "success and safety of needle knife papillotomy and fistulotomy based on papillary anatomy: a prospective controlled trial." literature summary: this study aimed to evaluate the validity and safety of this individualized therapy, the initial success rate of biliary cannulation (isrbc), and complication rates of patients who underwent nkp and nkf were compared prospectively among different types of mdps and between two precut approaches.A total of 188 out of 1674 patients undergoing ercp satisfied the criteria for early precutting: 75 patients were assigned to the nkp group and 113 to the nkf group.The total initial success rate of biliary cannulation (isrbc) of the precut techniques (both nkp and nkf) for patients with dbc was 91.5%.The isrbc of patients in the nkp group was similar to that of the nkf group (90.7% vs 92.0%, p>.05).The isrbc of the patients in the swollen mdp subgroup (96.1%) was higher than that of patients in the distorted mdp subgroup (81.8%, p=.030).The total and specific complications of the patients of the nkp group were similar to those of the nkf group (p>.05).This study concluded that nkp and nkf, as selected based on mdp anatomy, are equally safe and highly efficient for patients with dbc to allow biliary cannulation.Selecting a precut method based on mdp anatomy is an effective and safe strategy for patients with dbc.Type of adverse events/number of patients: acute pancreatitis (11), bleeding (4), cholangitis (1), perforation (1), initial unsuccess of biliary cannulation (16).This article includes 2 reports: (b)(6): jf-260v was selected to represent jf 260 documented in the article.(b)(6): kd-10q-1 was selected to represent kd-10-1 documented in the article.This report is 2 of 2 for (b)(6): kd-10q-1 and was selected to represent kd-10-1 documented in the article.
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
Additional information received from the author: the lot number is not available.No malfunctions occurred.The author reported the adverse events were attributed to the patient's underlying pathology and disease state and not the olympus device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the author and the legal manufacturer's investigation.New information added to the following fields: the device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.No malfunctions were reported.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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15142136
• Report Number: 9614641-2022-00079
• Device Sequence Number: 20226364
• Product Code: KNS
• UDI-Device Identifier: 04953170038051
• UDI-Public: 04953170038051
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K955247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2022

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-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: 07/04/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 09/06/2022
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JF-260V,UNK SERIAL; NON-OLYMPUS: GUIDEWIRE, SPHINCTEROTOME,GENERATOR
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown