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 Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The serial number of the suspect device is unknown.The device will not be returned to olympus for evaluation.The investigation is in progress.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled ¿histopathologic diagnosis discrepancies between preoperative endoscopic forceps biopsies and specimens resected by endoscopic submucosal dissection in superficial gastric neoplasms¿.Background: the standard of practice when a superficial lesion was identified during upper gi endoscopy is to take an endoscopic forceps biopsy (efb) of the lesion.The histopathologic findings then will determine the management plan.Endoscopic submucosal dissection (esd) enables en-bloc resection for early neoplasms of the gastrointestinal tract and provides an adequate specimen that permits a more reliable histopathologic assessment.The objective of this study was to determine the rate of histopathologic discrepancy between efb and specimens resected by esd, and to identify the predisposing risk factors for this discordance.Materials and methods: this is a retrospective study, enrolling patients with superficial gastric neoplasms that underwent efb followed by esd.We divided cases to concordant or discordant group according to the histopathologic diagnosis of efb and esd specimens.We also analyzed the features that may have influenced the occurrence of histopathologic discordance and the association between discordant samples of adenocarcinoma and neoplastic invasion to deeper layers.Results: a total of 115 gastric esd procedures were performed with 84 patients meeting the inclusion criteria.Histopathologic discordance between efb and esd specimens were observed in 35.8% of cases (30/84 lesions).The univariant-bivariant analysis and multivariate logistic regression analysis showed that histologic discordance was closely related to the size of the lesions (p =0.028).Conclusions : histopathologic discrepancy between efb and esd specimens may occur in approximately one-third of cases, particularly for lesions over 20 mm, which may lead to crucial delays in gastric cancer precise diagnosis and treatment.Type of adverse events/number of patients: late gastrointestinal bleeding: 2; there are two reports of complications that include two patients with reported late gastrointestinal bleeding.There is no report of an olympus device malfunction reported in the procedures described in this study.
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.This supplemental report includes information added to b5 and d9.Also, a correction has been made to e1 from the initial medwatch.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The following information was received: the authors declare that they have nothing to disclose.

• 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: 16400755
• Report Number: 9614641-2023-00243
• Device Sequence Number: 5592500
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2023

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
• Device Lot Number: LITERATURE (NO SERIAL)
• 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: 01/20/2023
• Supplement Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 03/15/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown