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

Model Number	D-201-11804
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Hemorrhage/Blood Loss/Bleeding (1888); Bowel Perforation (2668)
Date of Event	05/24/2023
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 "usefulness of the s-o clip for duodenal endoscopic submucosal dissection: a propensity score-matched study." this retrospective study evaluated the efficacy and safety of duodenal esd using an s-o clip for snadets.The retrospective study was patients who underwent esd for snadets between january 2011 and december 2021.Propensity score matching analysis was used to compare patients who underwent duodenal esd with the s-o clip (s-o group) and those who underwent conventional esd (control group).Sixty patients with snadets who were treated with esd were enrolled.After propensity score matching, 16 pairs were created: 43 and 17 in the s-o and control groups, respectively.All esd procedures were performed using a single-channel endoscope (gif-h260j) with a transparent hood (d-201-11804) and hook knife (kd-625lr).S-o group: 43 patients delayed bleeding: 2 patients control group: 17 patients intraoperative perforation: 4 patients delayed perforation: 1 patient in case of delayed complications, computed tomography and blood tests were performed.Delayed bleeding treated with endoscopic hemostasis after esd.Most of the cases of intraoperative perforation were successfully managed with conservative treatment alone.However, some cases required conversion to surgery.Another patient in the study developed a retroperitoneal abscess due to an intraoperative perforation and was hospitalized for 67 days.This literature article requires 3 reports.The related patient identifiers are as follows: (b)(6): gif-q260j (b)(6): kd-625lr (b)(6): d-201-11804 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.
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 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.Olympus will continue to monitor field performance for this device.

• Brand Name: DISPOSABLE DISTAL ATTACHMENT
• Common Device Name: 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: 18636449
• Report Number: 9614641-2024-00243
• Device Sequence Number: 7763426
• Product Code: FDS
• UDI-Device Identifier: 04953170453854
• UDI-Public: 04953170453854
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K984358
• 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): 03/15/2024

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: D-201-11804
• 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: 01/08/2024
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 03/15/2024
• 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: GIF-Q260J; KD-625LR
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown