MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. LONG CLIP

Model Number	HX-610-090L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/17/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Olympus reviewed the following literature article: "correlation between endoscopic resection outcomes and endosonographic findings in gastric tumors with muscularis propria origin." literature summary: this study was aimed to determine the correlation between endoscopic resection outcomes and endosonographic findings in gastric tumors with muscularis propria origin.Total 32 patients were included; tumors located in submucosa (group i, n=5), muscularis propria (group ii, n=14), and tumors extended into the outer cavity (group iii, n=13).In total, four patients experienced perforation which occurred in one patient in group i, one patient in group ii, and two patients in group iii and local recurrence occurred in two patients with incomplete emd resections.This study concluded that preprocedural eus predicted the layer of the tumor accurately; however, it was limited in the evaluation of the pattern of invasion.They found that tumors that were diagnosed as growing outward on eus rarely penetrated the muscularis propria and invaded the subserosal layer upon pathological examination.Eus has the limitations to evaluate the invasion patterns of tumors using eus.Type of adverse events/number of patients: [group i] perforation - 1 patient [group ii] perforation - 1 patient [group iii] perforation - 2 patients local recurrence - 2 patients hx-610-090l was selected for the olympus clips since they were shipped the most in the area and in the study period it-knife kd-610l was selected to represent one of the following devices used: it-knife, it knife-2, or hook knife this article includes 2 reports: (b)(6): hx-610-090l.(b)(6): kd-610l.This report is 1 of 2 for (b)(4): hx-610-090l.
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 event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The following additional information was received from the author: an olympus device did not cause or contribute to any of the adverse events described in the article.The products involved in the procedures were disposed of; therefore, the any further details regarding the devices are unknown.

• Brand Name: LONG CLIP
• Common Device Name: LONG CLIP
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15653341
• Report Number: 9614641-2022-00522
• Device Sequence Number: 17633806
• Product Code: PKL
• UDI-Device Identifier: 04953170200373
• UDI-Public: 04953170200373
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K183590
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2022

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: HX-610-090L
• 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: 09/25/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: KD-610L
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown