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

Model Number D-201-11802

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

Patient Problem Perforation (2001)

Event Date 12/01/2022

Event Type  Injury  

Event 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.

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.

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
• 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: 16439952
• MDR Text Key: 310233174
• Report Number: 9614641-2023-00266
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170048395
• UDI-Public: 04953170048395
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/24/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 02/24/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female