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

Model Number	PR-233Q
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)
Date of Event	04/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Olympus reviewed the following literature titled, "single-operator peroral cholangioscopy cystic duct cannulation for transpapillary gallbladder stent placement in patients with acute cholecystitis at moderate to high surgical risk (with videos)".Background: one of the main reasons for failed endoscopic transpapillary gallbladder stenting (etgs) under fluoroscopic guidance is the inability to cannulate the cystic duct.Single-operator peroral cholangioscopy (soc)-assisted etgs is an adjunct technique to facilitate etgs.We aimed to demonstrate its efficacy.Methods: between 2015 and 2019, 104 patients with acute cholecystitis at moderate to high surgical risk underwent etgs, which involved 3 steps: (1) cystic duct cannulation under fluoroscopic guidance with or without additional soc guidance; (2) guidewire placement; and (3) stent placement in the gallbladder.The technical success rate was determined when stent placement was confirmed endoscopically and radiographically.Results: of 104 patients, 55 (53%) patients had successful etgs under fluoroscopic guidance.Of 49 patients who had failed fluoroscopy-guided etgs, 41 patients underwent additional soc-assisted etgs and 5 patients proceeded to other interventions.Of patients who underwent soc-assisted etgs (n z 41), 23 (56%) cystic cannulation followed by stent placement were successful; cystic duct cannulations, guidewire, and stent placement failed in 8, 9, and 1 patients, respectively.The overall technical success rate of etgs increased from 53% (55 of 104) to 75% (78 of 104) after additional soc assistance.Adverse events and recurrence were not different between patients who underwent etgs under fluoroscopic guidance and those who underwent soc-assisted etgs.Conclusions: in patients with acute cholecystitis who are not surgical candidates, soc-assisted etgs can increase the technical success rate after failed fluoroscopic guidance.Soc can help for the cystic duct cannulation and guidewire placement steps but not for the stent placement step.Type of adverse events/number of patients bleeding - 3 patients perforation due to guidewire - 2 patients pancreatitis - 1 patient *fever was reported in 2 patient, and considered a non-serious event.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6) (pr-233q).(b)(6) (tjf-q180v).There is no report of any olympus device malfunction in any procedure described in this study.
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.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: DISPOSABLE BENDING CANNULA
• Common Device Name: DISPOSABLE 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: 16679177
• Report Number: 9614641-2023-00464
• Device Sequence Number: 8116149
• Product Code: ODD
• UDI-Device Identifier: 04953170044243
• UDI-Public: 04953170044243
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K011149
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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-233Q
• 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: 03/05/2023
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 05/03/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NON-OLYMPUS: GLO-TIP; NON-OLYMPUS: SPYGLASS; NON-OLYMPUS: ULTRATOME XL; NON-OLYMPUS: VISIGLIDE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown