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

Model Number	D-201-13404
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the literature described "multi-bending double channel videoendoscope evis-gifq260m", olympus selected "gif-2tq260m" as a appropriate product.The suspect device has not been returned to olympus for evaluation.The device history record was unable to be reviewed for this device since no product malfunction was reported.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely the reported event is an accident, or a complication associated with a surgical procedure using the subject device.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "outcomes of endoscopic full-thickness resection for gastric submucosal tumors, a prospective study".In a histologically proven small gastrointestinal stromal tumor (gist), standard treatment is excision, unless major morbidity is expected.Currently, the standard method to excise the gastric gist is surgery.However, outcomes of endoscopic full-thickness resection (eftr) for treatment of gastric gist are reported mainly from china.In september 2020, eftr was approved as an advanced medical care for gastric smts in japan.Type of adverse events/number of patients: delayed perforation (n=1).Additional information from the author stated that in the end, the perforation was sutured with an indwelling snare and a clip so there was a possibility that it was loose, but the cause is unknown.Additionally, the author confirmed no olympus equipment malfunctioned during the case.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6) - d-201-13404 ; (b)(6) - gif-2tq260m.This report is for patient identifier (b)(6).

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17317083
• Report Number: 9614641-2023-00978
• Device Sequence Number: 12285872
• Product Code: FDS
• UDI-Device Identifier: 04953170453885
• UDI-Public: 4953170453885
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2023

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-201-13404
• 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: 06/15/2023
• Initial Report FDA Received Date: 07/13/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GIF-2TQ260M
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown