MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. ROTATABLE CLIP FIXING DEVICE

Model Number	HX-110LR
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	10/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to olympus for evaluation.The literature article is attached for additional information.Doi.Org/10.5230/jgc.2023.23.E37 provided for additional information.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
Olympus reviewed the literature titled: "indications for dental floss clip traction during gastric endoscopic submucosal dissection by less-experienced endoscopists." this retrospective study investigated the indications of dental floss clip (dfc) in endoscopic submucosal dissection (esd) performed by less-experienced endoscopists for early gastric cancer.A total of 812 patients were included.The procedure time in the dfc (+) group was significantly shorter than that in the dfc (-) group (95±46 vs.75±31, p<0.01).The procedure time for lesions located in the greater curvature of the upper or middle stomach and lesions >20 mm located in the lesser curvature side of the stomach in the dfc (+) group was significantly shorter than that in the dfc (-) group.Type of adverse events/number of patients: delayed bleeding - 30 patients, perforation - 10 patients.Delayed bleeding was defined as clinical bleeding after esd that required blood transfusion or endoscopic or surgical intervention.Perforation was diagnosed when mesenteric fat or intra-abdominal space was observed during the procedure or when free air was identified on simple chest and abdominal radiographs after esd.Related patient identifiers: (b)(6) - evis lucera gastrointestinal videoscope (gif-q260j).(b)(6) - disposable distal attachment (d-201-11804).(b)(6) - single use electrosurgical knife (kd-611l).(b)(6) - single use electrosurgical hemostatic forceps (fd-410lr).(b)(6) - rotatable clip fixing device (hx-110lr).(b)(6) - clip (hx-610-090).There is no report of any olympus device malfunction in any procedure described in this study.This medwatch is for patient identifier (b)(6).
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 events 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.

• Brand Name: ROTATABLE CLIP FIXING DEVICE
• Common Device Name: ROTATABLE CLIP FIXING DEVICE
• 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: 18515225
• Report Number: 9614641-2024-00087
• Device Sequence Number: 7698091
• Product Code: PKL
• 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,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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
• 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: 12/18/2023
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 01/15/2024
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CLIP (HX-610-090); DISPOSABLE DISTAL ATTACHMENT (D-201-11804); ELECTROSURGICAL HEMOSTATIC FORCEPS (FD-410LR); GASTROINTESTINAL VIDEOSCOPE (GIF-Q260J); SINGLE USE ELECTROSURGICAL KNIFE (KD-611L)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown