MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. 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 Code	Perforation (2001)
Date of Event	03/12/2021
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, "investigation of endoscopic transpapillary gallbladder drainage for acute cholecystitis-technical tips for difficult cases of cystic duct infusion".Endoscopy for acute cholecystitis mirror transpapillary cystic duct drainage (etgbd) is effective in cases of ascites and bleeding tendency.However, compared to other ercp-related procedures, etgbd has a low success rate and often encounters situations where it is difficult to complete the procedure.This time, we examined the treatment results of etgbd for acute cholecystitis in our hospital.It also introduces technical tips for treatment.A retrospective study was conducted on 41 patients who underwent etgbd for acute cholecystitis at our hospital between january 2015 and july 2021.There were 28 males and 13 females with a median age of 80 years (58-91), and the severity of disease was mild in 27 patients (65.9%), moderate in 13 (31.7%), and severe in 1 (2.4%).Intracolonic, ductal, and common bile duct stones were found in 30 (73.2%), 13 (31.7%), and 16 (39.0%) patients, respectively.The bifurcation of the ileocecal duct was as follows: high/low: 36/5, head/foot: 35/6, right side/left side: 34/7.The procedure success rate was 95.1% (39/41) (etbs/engbd: 34/5), and the treatment response rate was 100% (39/39).We defined difficult cholecystostomy as cases in which the conventional device could not be used to intubate the gallbladder.Of the 12 cases of difficult intubation, 7 cases could be intubated using the swingtiptm cannula (olympus), which allows control of the angle of the catheter tip.In addition, two patients with severe bile duct stenosis and difficulty in intubation even with the swingtiptm cannula were able to break through the stenosis with the long tapered cannula ((b)(4)).This article includes 2 reports for swingtiptm cannula and startipvtm olympus devices for the reported adverse event: (b)(6) for disposable bending cannula/swing tip (pr-233q) (b)(6) for startipv long taper tip (pr-v220q) 1 case of gallbladder duct perforation.This is report 1 of 2 for (b)(6) for disposable bending cannula/swing tip (pr-233q).
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and additional information from the author.Device history records review was not performed since the serial number was not provided.Olympus ships product manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.
Event or Problem Description
Additional information provided by the customer: surgery was performed immediately after and the prognosis is good.The physician stated he thinks the event was due to the guidewire.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation 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.Olympus will continue to monitor field performance for this device.

• Brand Name: DISPOSABLE BENDING CANNULA
• Common Device Name: DISPOSABLE CANNULA
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13603699
• Report Number: 8010047-2022-03599
• Device Sequence Number: 1856907
• Product Code: ODD
• UDI-Device Identifier: 04953170044243
• UDI-Public: 04953170044243
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2022

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: 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: 01/26/2022
• Supplement Date Received by Manufacturer: 03/17/2022; 07/25/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 04/15/2022; 08/16/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown