MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. 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)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature: "endoscopic full-thickness resection versus endoscopic submucosal dissection in the treatment of colonic neoplastic lesions = 30 mm¿a single-center experience."    literature summary: the purpose of the analysis was to evaluate efficacy and safety of full-thickness resection (ftr) in the treatment of colorectal lesions = 30 mm by comparing prospectively followed ftr cohort to retrospective submucosal dissection (esd) cohort in the setting of single tertiary endoscopy center.Primary outcomes were technical success rate, r0 resection and curative resection rate, and complication rate.A total of 52 patients in ftr and 50 patients in esd group were treated between 2015 and 2018.Technical success rate was significantly higher in ftr group (92 vs.74%, p = 0.01) as well as r0 resection rate (85 vs.62%, p = 0.01) and curative resection rate (75 vs.56%, p = 0.01).Complications occurred more frequently in esd group (40 vs.13%, p = 0.002), mainly due to high incidence of electrocoagulation syndrome (24 vs.0%).Total procedure time was substantially shorter in ftr group (26.4 ± 11.0 min vs.Estimated 90¿240 min).Local residual neoplastic lesions were detected numerically more often in ftr group (12 vs.5%, p = 0.12).No patient died during follow-up.Compared to esd, ftr proved significantly higher technical success rate, higher r0 and curative resection rate, and shorter procedure time.In the ftr group, there were significantly less complications but higher incidence of local residual neoplasia.Further research including randomized trials is needed to compare both resection techniques.Perforation occurred in 1 case in the ftr and in 4 cases in the esd group.In both groups, there were 4 cases of delayed bleeding.In esd group, there were 20 cases of electrocoagulation syndrome while none in ftr group.Two cases of acute appendicitis following ftr of periappendicular lesions were treated conservatively.No patient died during this study and follow-up.Type of adverse events/number of patients ftr group: perforation - 1 patient.Delayed bleeding - 4 patients.Acute appendicitis - 2 patients.Esd group: perforation - 4 patients: delayed bleeding - 4 patients: coagulation syndrome - 12 patients.This article includes 8 reports: (b)(6) : kd-650u - esd only group adverse events.(b)(6) : kd-655u - esd only group adverse events.(b)(6) : fd-411ur - esd only group adverse events.(b)(6) : hx-110ur - esd only group adverse events.(b)(6) : hx-201yr-135 - esd only group adverse events.(b)(6) : d-201-14304 - esd only group adverse events.(b)(6) : cf-h180al - for all adverse events.(b)(6) : cf-hq190l - for all adverse events.This report is 3 of 8 for: (b)(6) : fd-411ur - esd only group adverse events.
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
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 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: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• Common Device Name: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• 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: 14856860
• Report Number: 8010047-2022-11052
• Device Sequence Number: 5309865
• Product Code: KNS
• UDI-Device Identifier: 04953170251542
• UDI-Public: 04953170251542
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2022

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: FD-411UR
• 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: 05/30/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 08/01/2022
• 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: UNK LOT: HX-110UR OR HX-201YR-135; UNK LOT: KD-650U OR KD-655U; UNK SERIAL: (B)(6)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown