MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE DISTAL ATTACHMENT

Model Number D-201-10704

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Date 05/20/2022

Event Type  Injury  

Manufacturer Narrative

He serial number of the suspect device is unknown.The device will not be returned to olympus for evaluation.The investigation is in progress.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted.

Event Description

Olympus medical systems corp.(omsc) received a literature titled "competence development of trainees performing short-type single-balloon enteroscopy-assisted endoscopic retrograde cholangiopancreatography in patients with surgically altered anatomy.¿ objectives this study aimed to evaluate the trainees' practice and learning curve in short-type single-balloon enteroscopy (short sbe)-assisted endoscopic retrograde cholangiopancreatography (ercp) for patients with surgically altered anatomy (saa) and determine how to train these trainees.Methods: the data of short sbe-assisted ercp procedures between september 2011 and june 2021 were analyzed.Results: three trainees and 180 cases were included in the analysis.Each trainee performed 60 cases between (b)(6) 2016 and (b)(6) 2021.The trainees' completion rate was 73.9% (95% confidence interval [ci], 66.8-80.1%).Adverse events occurred in 5.0% of cases (95% ci, 2.3-9.3%).The trainee who experienced colonoscopy and ercp the most achieved better outcomes of enteroscopy success (reaching the target site) and trainee's completion rates than those of the others (p =.03 and.02, respectively).The learning curve for trainee's completion showed a significant improvement after 60 cases (p =.001).Multiple logistic regression analysis indicated that roux-en-y reconstruction was the factor affecting trainees' completion failure.Conclusions: short sbe-assisted ercp trainees has a substantial learning curve.If trainees do not have much experience with colonoscopy and ercp procedures, it may be beneficial for them to start performing short sbe-assisted ercp procedures on non-roux-en-y reconstruction cases.Type of adverse events/number of patients: pancreatitis/4; cholangitis /4; intestinal perforation /1.This literature article required 3 reports.The related patient identifiers are the following: (b)(6): sif-h290s.(b)(6): d-201-10704.(b)(6): sif-h290s.This medwatch report is for patient identifier: (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

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 information added to b5 and d8.Also, a correction has been made to e2, e3 and e4 to provide information that was inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.

Event Description

The following additional information was received: the events described in this article were not caused by an olympus device.In addition, there were no device malfunctions.

• Brand Name: DISPOSABLE DISTAL ATTACHMENT
• Type of Device: DISPOSABLE DISTAL ATTACHMENT
• 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: 16440660
• MDR Text Key: 310233034
• Report Number: 9614641-2023-00272
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K984358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

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
• Device Operator: Health Professional
• Device Model Number: D-201-10704
• 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
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other