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

Model Number	D-201-11802
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled "treatment strategy for giant 0-is tumors exhibiting muscle layer traction in our hospital".Huge 0-is (stemless) tumors of the large intestine may exhibit high fibrosis and muscle traction, and are considered to be highly difficult cases of esd.In the past, muscle layer traction was one of the guidelines for stopping esd, but it is becoming a lesion that can be overcome by the progress of esd devices including traction devices and various treatment methods such as the tunnel method and pocket-creation method reported by yamamoto, hayashi et al.In our hospital, the tunnel method is the basic strategy for huge 0-is type tumors, and the double tunnel method (dt method) is used for cases with severe fibrosis and muscle layer traction in the center, and the outline of the method is explained.Type of adverse events/number of patients, intraoperative perforation - 1 patient, delayed perforation - 1 patient.This literature article requires 10 reports.The related patient identifiers are as follows: 1.(b)(6): (b)(4) for a patient in case#2 with intraoperative perforation, 2.(b)(6): (b)(4) for a patient in case#2 with intraoperative perforation, 3.(b)(6): (b)(4) for a patient in case#2 with intraoperative perforation, 4.(b)(6): (b)(4) for a patient in case#2 with intraoperative perforation, 5.(b)(6): (b)(4) for an unknown patient with delayed perforation, 6.(b)(6): (b)(4) for an unknown patient with delayed perforation, 7.(b)(6): (b)(4) for an unknown patient with delayed perforation, 8.(b)(6): (b)(4) for an unknown patient with delayed perforation, 9.(b)(6): (b)(4) for an unknown patient with delayed perforation, 10.(b)(6):( b)(4) for an unknown patient with delayed perforation.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
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.
Additional Manufacturer Narrative
This report is being supplemented to provide the component code article inadvertently omitted from the initial medwatch report.(see h6).

• 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: 16439952
• Report Number: 9614641-2023-00266
• Device Sequence Number: 20664168
• Product Code: FDS
• UDI-Device Identifier: 04953170048395
• UDI-Public: 04953170048395
• 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): 02/24/2023

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-201-11802
• 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: 02/24/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 02/24/2023
• 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 Age: 75 YR
• Patient Sex: Female