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

Model Number	FD-411QR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Bowel Perforation (2668)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to the following linked patient identifiers: (b)(6).Since the literature described "hemostatic forceps", olympus selected "fd-411qr" as a representative product.The device has not been returned to olympus for evaluation.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.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
Olympus reviewed the following literature titled "efficacy and safety comparison of scissor-type knives with needle-type knives for colorectal endoscopic submucosal dissection: a post-hoc propensity score-matched analysis".Background and aims: many knives have been developed to improve the efficacy and safety of endoscopic submucosal dissection (esd).We aimed to evaluate the efficacy and safety of scissor-type knives for colorectal esd compared with needle-type knives.Methods: we performed a post-hoc propensity score¿matched analysis in an 11-facility study between august 2013 and december 2018.A total of 2330 patients (2498 lesions) who underwent colorectal esd were divided into needle-type (1923 patients, 2067 lesions) and scissor-type (407 patients, 431 lesions) knife groups.Short-term outcomes were compared between the 2 groups.Results: two-to-one propensity score-matched analysis identified 814 (709 patients) and 407 (386 patients) lesions in the needle-and scissor-type knife groups, respectively.The median resection speed was significantly faster in the needle-type group (18.3mm2/min) than in the scissor-type group (13.2mm2/min, p <.0001), whereas en-bloc and histologic complete resection rates were not significantly different between the needle- and scissor-type groups (96.8%[788/814] vs 98.3%[400/407], pz.1888 and 95.1%[774/814] vs 95.6%[389/407], pz.7763, respectively).The rate of lesions resected using a single knife was significantly higher in the scissor-type group (98.5% [401/407]) than in the needle-type group (43.9% [357/814], p<.0001).Rates of intraoperative perforation and delayed bleeding were significantly lower in the scissor-type group than in the needle-type group (.7% [3/407] vs 2.5% [20/814], pz.0431 for each).Table 3 - outcomes of endoscopic submucosal dissection for colorectal tumors needle-type: intraoperative perforation (66 patients).-intraoperative perforation requiring surgery (5 patients).Delayed perforation (5 patients).-delayed perforation requiring surgery (5 patients).Delayed bleeding (47 patients).Scissor type: intraoperative perforation (3 patients).-intraoperative perforation requiring surgery (1 patient).Delayed bleeding (3 patients).Conclusions: scissor-type knives are safer for colorectal esd.However, they are associated with slower resection speeds compared with needle-type knives.

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21608174
• Report Number: 9614641-2025-00316
• Device Sequence Number: 21136572
• Product Code: KNS
• UDI-Device Identifier: 04953170251535
• UDI-Public: 04953170251535
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2025

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-411QR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown