MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. CANNULA

Model Number	PR-110Q-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pancreatitis (4481); Cholangitis (4821)
Date of Event	10/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled "the usefulness of peroral cholangioscopy for intrahepatic stones." literature summary: this single-center retrospective study examined the results of transpapillary treatment of intrahepatic stones.A total of 26 patients were included.Complete stone removal (csr) was achieved in 92% (24/26) of cases; csr was not achieved in two cases.One case was an intrahepatic stone found incidentally and judged unnecessary to treat.The other case was after a bile duct resection for congenital biliary dilatation, and the double-balloon endoscope could not reach the anastomosis site.The median procedure time for the first session was 97 (27¿220) minutes, whereas that of the ehl under pocs group was 121 (43¿213) minutes and that of the fluoroscopic guidance group was 77 (27¿220) minutes, indicating that the ehl under pocs group had a significantly longer procedure time (p = 0.0195, mann¿whitney u test).In conclusion, endoscopic treatment for intrahepatic stones should be performed at established centers, because specialized devices such as a cholangioscope may be required and cholangitis may increase.Cholangitis developed in six (24%) and pancreatitis in three (12%) cases after the first session; however, all cases were mild and could be treated conservatively including antibiotic treatment.Although the incidence of cholangitis was high, there were no differences in complication rates between patients with and without ehl under pocs (p = 1, chi square test).Type of adverse events/number of patients: pancreatitis - 3 patients, cholangitis - 6 patients.This literature article requires 4 reports.The related patient identifiers are as follows: (b)(6): tjf-q290v duodenovideoscope, (b)(6): jf-260v duodenovideoscope, (b)(6): cf-hq290zi colonovideoscope, (b)(6): pr-110q-1 catheter.This medical device 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.The investigation is in process.A supplemental report will be submitted upon completion of the investigation or if additional information is received.The literature is attached for additional information.
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 events cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.In addition, the malfunction of the device has not been reported, and from clinical/medical evaluation and risk assessment, it is possible that the reported event is an accident, or a complication associated with a procedure using the subject device.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The author believes that this is a complication that occurs during the procedure as a whole, not because of the device.

• Brand Name: CANNULA
• Common Device Name: CANNULA
• 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: 17482372
• Report Number: 9614641-2023-01113
• Device Sequence Number: 15213223
• Product Code: ODD
• UDI-Device Identifier: 04953170043765
• UDI-Public: 04953170043765
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K950729
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2023

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: PR-110Q-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: 07/10/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/25/2023
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CF-HQ290ZI COLONOVIDEOSCOPE; JF-260V DUODENOVIDEOSCOPE; TJF-Q290V DUODENOVIDEOSCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown