MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS

Model Number	FD-411UR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the literature described "coagrasper", olympus selected "fd-411ur" as a representative product.E1: (b)(6) hospital.Health effect - clinical code 4581 is used for esophageal stricture, transient pneumomediastinum, and subcutaneous emphysema.The suspect device has not been returned to olympus.Additional information has been requested but no information could be provided.The literature is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "learning curve in esophageal endoscopic submucosal dissection by western endoscopists trained in japan: experience in latin america".Abstract background: esophageal endoscopic submucosal dissection (eesd) is a complex and time-consuming procedure at which training are mainly available in japan.There is a paucity of data concerning the learning curve to master eesd by western endoscopists.Objective: this study aimed to assess the learning curve effect on patient¿s clinical outcome for eesd.Methods: this is a retrospective observational study.Enrolling patients that underwent eesd from 2009 to 2021.The analysis was divided into two periods; t1: case 1 to 49 and t2: case 50 to 98.The following features were analyzed for each group: patients and tumors characteristics, en-bloc, complete and curative resection rates, procedure duration and adverse events rate.Results: ninety-eight eesd procedures were performed.Mean procedure time was 111.8 min and 103.6 min for t1 and t2, respectively (p=0.004).En bloc resection rate was 93.8% and 97.9% for t1 and t2, respectively (p=0.307).Complete resection rate was 79.5% and 85.7% for t1 and t2, respectively (p=0.424).Curative resection rate was 65.3% and 71.4% for t1 and t2, respectively (p=0.258).Four patients had complications; three during t1 period and one during t2 period.Overall mortality rate: 0%.One patient had transient pneumomediastinum and subcutaneous emphysema noted in the postoperative period with resolution in 24 hours.A total of four adverse events occurred during the study period.During the t1, there were two cases of perforation and one case of bleeding (table 2).During the t2, there was a single case of perforation, suggesting a decrease in the complication rate in the second period, without being statistically significant difference though.All adverse events were successfully managed endoscopically by thermal coagulation and clips closure (mortality rate: 0%).In addition, evidence over time showed three cases of esophageal stricture (non-operator-dependent complications) which had all resolved with balloon dilation.Conclusion: the esophageal endoscopic submucosal dissection could be performed effectively and safely by an adequately trained western endoscopist.Type of adverse events/number of patients: perforation (3).Bleeding (1).Esophageal stricture (3).Transient pneumomediastinum and subcutaneous emphysema with resolution in 24 hours (1).There is no report of any olympus device malfunction in any procedure described in this study.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information received from the author as reflected on b5.
Event or Problem Description
Olympus received further information indicating that according to the author, there was no problem related to the olympus device.
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.

• Brand Name: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• Common Device Name: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• 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: 17922968
• Report Number: 9614641-2023-01515
• Device Sequence Number: 6782779
• Product Code: KNS
• UDI-Device Identifier: 04953170251542
• UDI-Public: 04953170251542
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K062517
• 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,Followup
• Report Date (Section B): 10/25/2023

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: FD-411UR
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 10/20/2023; 10/25/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 10/23/2023; 10/25/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown