MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE EMR KIT

Model Number	K-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the literature described "emr kit", olympus selected "k-001" as a representative product.An ultrasound probe (maj-935) was used to assess the depth of invasion and was not associated with any adverse events.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 "potential risk during endoscopic management of large duodenal polyps." this multi-center retrospective study reviews the patient characteristics, emr techniques, procedure outcomes, adverse events, and recurrence of large duodenal polyps in 65 patients.Complete resection of the visible mass was achieved in 96.9% of cases.This study concludes that the talented endoscopists are critically required for endoscopic management of large duodenal polyps.While most immediate adverse events can be managed endoscopically, all preventive measures for delayed perforation should be applied before completing emr as these usually require surgical intervention.Type of adverse events/number of patients.Intraoperative bleeding - 12 patients.Delayed perforation - 2 patients.Delayed bleeding - 7 patients.Recurrence - 11 patients.This literature article requires 3 reports.The related patient identifiers are as follows: (b)(6) : gif-q180.(b)(6) : tjf-160f.(b)(6) : k-001.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 supplemental report is being submitted to provided additional information from the author and to provide additional information based on the legal manufacturer's final investigation.New information added to the following fields: b5 and h6.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
In the medical opinion of the author, the olympus device did not cause malfunction nor the adverse events reported.

• Brand Name: DISPOSABLE EMR KIT
• Common Device Name: DISPOSABLE EMR
• 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: 15973820
• Report Number: 9614641-2022-00760
• Device Sequence Number: 6960265
• Product Code: FDS
• UDI-Device Identifier: 04953170048562
• UDI-Public: 04953170048562
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/12/2023

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: K-001
• 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: 11/13/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/12/2023
• 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: NON-OLYMPUS ACUSNARE; NON-OLYMPUS ENDOCUT Q MODE VIO 300D; OLYMPUS GIF-Q180; OLYMPUS TJF-160F
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown