MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. BIOPSY FORCEPS

Model Number	FB-25K-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled "cost-effectiveness and short-term clinical outcomes of argon plasma coagulation compared with endoscopic submucosal dissection in the treatment of gastric low-grade dysplasia".This was a retrospective review study was aimed to evaluate the endoscopic submucosal dissection (esd) vs.Clinical efficacy of argon plasma coagulation (apc) for gastric low-grade dysplasia (lgd) in terms of clinical efficacy and cost-effectiveness.The study included 183 patients, divided into the apc group (n=59) and esd group (n=124).The study claimed that the mean procedure time, mean hospital stay, and procedure cost was significantly shorter in the apc group than in the esd group (p<.01).A residual tumor was evident in one patient after apc treatment, but not in the esd group, the residual tumor was treated by apc again, and no recurrence occurred during the follow-up period.It concluded apc as advantageous over esd related to safety and cost-effectiveness compared with esd.Therefore, apc can be considered an alternative treatment option for gastric lgd.The authors reported using 8 different olympus devices and did not specify the olympus device used in relation to the adverse event and therefore, all will be reported.(b)(6)- kd-611l; (b)(6)- gif-h260; (b)(6)- gif-q260; (b)(6)- gif-q260j; (b)(6)- gif-h260z; (b)(6)- gif-h290; (b)(6)- fb-25 k-1; (b)(6)- kd-630l.The adverse events reported: 2 patients with massive bleeding: massive bleeding was defined as a decrease in blood hemoglobin level of = 2 g/dl that was accompanied by the occurrence of hematemesis, melena, or the combination of unstable vital signs, and fresh blood, or clots upon levin tube irrigation within 4 weeks after the endoscopic treatment; successfully, managed using an endoscopic hemostatic technique (hemoclip or electric coagulation), and recovered completely.24 patients with delayed bleeding was defined as post-procedural bleeding requiring additional endoscopic management, and a post-procedure lesion belonging to forrest classification ia, ib, or iia; successfully, managed using an endoscopic hemostatic technique (hemoclip or electric coagulation), and recovered completely.2 patients with microperforations: detected by the presence of free air on plain radiographs taken after the procedure; each recovered completely, after conservative management.This is report 7 of 8 for (b)(6)- fb-25 k-1.
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: BIOPSY FORCEPS
• Common Device Name: BIOPSY 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: 13564069
• Report Number: 8010047-2022-03271
• Device Sequence Number: 1857197
• Product Code: EOQ
• UDI-Device Identifier: 04953170030055
• UDI-Public: 04953170030055
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K962555
• 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): 05/02/2022

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: FB-25K-1
• 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: 01/23/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GIF-H260 OR GIF-Q260.; GIF-Q260J, GIF-H260Z OR GIF-H290.; KD-630L, KD-611L.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Other
• Patient Sex: Unknown