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	Abdominal Pain (1685); Fever (1858); Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Perforation (2001)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to the following linked patient identifiers: (b)(6).The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "risk factors and a nomogram for prediction of post-endoscopic submucosal dissection electrocoagulation syndrome for superficial colorectal lesions".Literature summary background post-endoscopic submucosal dissection electrocoagulation syndrome (peecs) is an uncommon complication after colorectal endoscopic submucosal dissection (esd).This study aimed to explore the risk factors of peecs for superficial colorectal lesions based on the latest and consistent diagnostic criteria and to establish a predictive nomogram model.Methods this retrospective analysis included patients with superficial colorectal lesions who underwent endoscopic submucosal dissection (esd) between june 2008 and december 2021 in our center.The independent risk factors of peecs for superficial colorectal lesions were identified using least absolute shrinkage and selection operator (lasso) logistic regression analysis, as well as univariate analysis and multivariate logistic regression, and derived predictive nomogram model was constructed.Results among the 555 patients with superficial colorectal lesions enrolled, peecs occurred in 45 (8.1%) patients.Multivariate logistic regression revealed that female sex (or 3.94, p < 0.001), age > 50 years (or 4.28, p = 0.02), injury to muscle layer (or 10.38, p < 0.001), non-lifting sign (or 2.20, p = 0.04) and inadequate bowel preparation (or 5.61, p < 0.001) were independent risk factors of peecs for superficial colorectal lesions.A predictive nomogram model was constructed based on the above five predictors.For this model, the area under the receiver operating characteristic (roc) curve was 0.855, the calibration curve exhibited good consistency between the prediction and the actual observation, and the c-index was confirmed as 0.843 by bootstrap method.Conclusion female sex, age > 50 years, injury to muscle layer, non-lifting sign and inadequate bowel preparation were independent risk factors of peecs for superficial colorectal lesions.The proposed nomogram could accurately predict the risk of peecs for superficial colorectal lesions.Type of adverse events/number of patients intraoperative perforation (72) delayed perforation (3) intraoperative bleeding (280) delayed bleeding (36) postoperative fever (166) post-endoscopic submucosal dissection electrocoagulation syndrome (45) postoperative fever (127) localized abdominal pain or tenderness (45) fever (39) inflammatory response (27).
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 reported event was likely an accident, or a complication associated with a surgical procedure while using the subject device.There was no complaint reported on the subject device and 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: 20214383
• Report Number: 9614641-2024-01824
• Device Sequence Number: 15285868
• Product Code: KNS
• UDI-Device Identifier: 04953170251535
• UDI-Public: 04953170251535
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 12/02/2024

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: FD-411QR
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ELECTROSURGICAL KNIFE, KD-655Q, SN-UNK; HOOK KNIFE ELECTROSURGICAL KNIFE, KD-620QR, SN-UNK; SCOPE DISTAL ATTACHEMENT, D-201-11802, SN-UNK; SCOPE DISTAL ATTACHEMENT, D-201-11802, SN-UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown