MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ROTATABLE CLIP FIXING DEVICE

Model Number	HX-110LR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus medical systems corporation received a literature titled "feasibility study of partial submucosal injection technique combining underwater emr for superficial duodenal epithelial tumors." literature summary: this prospective observational study explained feasibility and safety of partial submucosal injection combining under water endoscopic mucosal resection (pi-uemr) for superficial duodenal tumor (sdet).A total of 30 patients were involved which underwent pi-uemr using gif-q260j or gif-h290t- gastroscope, endoscopic snare, endoscopic clip and many other devices.En bloc resection rate was 97%.R0 resection rate was 83%.Mean total procedure time was 17±12 min.Complications like intraoperative bleeding was observed in one case and during histological findings 29 cases of tubular adenoma and one case of duodenitis were observed.The study concluded that pi-uemr might be very useful and safe technique of endoscopic resection for sdet including relatively large lesions.Type of adverse events/number of patients: intraoperative bleeding (1) histological findings: tubular adenoma 29), duodenitis (1) since the literature described "snaremaster (10, 15, or 20 mm)", we selected "sd-210l-10" as a representative product.The product was unknown, but a representative product was chosen for processing purposes.Since the literature described "ez clip", we selected "hx-110lr" as a representative product.The product was unknown, but a representative product was chosen for processing purposes.Four reports were created based on this literature to specifically account for those olympus devices used in this study and they are as follows: (b)(6) which is for the disposable electrosurgical snare (b)(6) which is for hx-110lr, (b)(6) which is for gif-q260j, (b)(6) , which is for gif-h290t.
Additional Manufacturer Narrative
No device was returned to olympus for evaluation, and based on the literature, there was no allegation of device malfunction.The exact cause of the patient¿s outcome cannot be conclusively determined.However, it was reported that the intraoperation bleeding was controlled by utilizing a hemostatic forceps, and there were no delayed complications.If new and relevant information becomes available later, this report will be supplemented accordingly.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the updates in b3, d4, h6, and h10.The device history record was unable to be reviewed for this device since the 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.Olympus will continue to monitor field performance for this device.

• Brand Name: ROTATABLE CLIP FIXING DEVICE
• Common Device Name: ROTATABLE CLIP FIXING DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14580422
• Report Number: 8010047-2022-09315
• Device Sequence Number: 5526229
• Product Code: MND
• UDI-Device Identifier: 04953170200182
• UDI-Public: 04953170200182
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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-110LR
• 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: 05/05/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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-H290T SERIAL NUMBER UNKNOWN; GIF-Q260J SERIAL NUMBER UNKNOWN; SNAREMASTER MODEL SD-210L10 LOT NUMBER UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown