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 Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "technique description gel immersion emr (under-gel emr) for duodenal tumors - a new endoscopic resection method for superficial non-papillary duodenal tumors." literature summary: although the importance of endoscopic resection of duodenal tumors is becoming increasingly recognized, emr is associated with a certain frequency of bleeding, perforation, and other complications.In recent years, the usefulness of underwater emr, in which the lesion is flooded without local injection and resected by snaring, has been increasingly reported.However, some lesions are difficult to collect water in certain areas, and visibility may be reduced under water due to residuals.Therefore, there have been a number of reports on gel immersion emr (under-gel emr), in which the lesion is immersed using a gel to secure the field of view during endoscopic hemostasis, instead of water.This paper describes the method and prospects of this technique.Patients were diagnosed with adenomas by preoperative endoscopic biopsy or by endoscopic diagnosis.Fourteen patients with 14 lesions were treated with uemr and 15 patients with 17 lesions were treated with giemr.No perforation or delayed bleeding was observed in either group.Intraoperative bleeding occurred in one case in the giemr group and one case in the uemr group, but both cases could be stopped with a clip.No other serious complications were observed in either group.Conclusion giemr is safe and useful for snadets, and the procedure time is reduced compared to uemr.Gel immersion may also be useful in ep for papillary tumors, including postoperative reconstructed intestine.However, further case series are needed because this study was performed in a small number of patients.Type of adverse events/number of patients.Intraoperative bleeding - 2 patients.This literature article requires 4 reports.The related patient identifiers are as follows: (b)(6).This medwatch report is for (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.Additional information has been requested.The literature is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.
Event or Problem Description
Olympus received further information indicating that the author has confirmed that the adverse events described in the literature were not from the olympus devices and that there was no malfunction of any kind with the olympus devices.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information received as reflected on b5.Please see updates to b5 and h10.
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.

• 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: 17807672
• Report Number: 9614641-2023-01386
• Device Sequence Number: 7183945
• 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,Followup
• Report Date (Section B): 10/13/2023

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: 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: 08/31/2023
• Supplement Date Received by Manufacturer: 10/02/2023; 10/10/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/02/2023; 10/13/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown