MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number	WA22355C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the literature described "bipolar turis needle system", we selected (b)(6), as a representative product.Since the literature described "conventional loop-type electrode", we selected (b)(6), as a representative product.The product was unknown but a representative product was chosen for processing purposes, respectively.This was a multi-center retrospective cohort.The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Doi.(b)(6).Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
Olympus reviewed the following literature titled: "en bloc resection versus conventional turbt for t1hg bladder cancer: a propensity score-matched analysis." this study aimed to clarify the perioperative, oncologic, and pathologic outcomes of en bloc resection of bladder tumors (erbt) for patients with pt1 bladder cancer (bca) compared with conventional transurethral resection of bladder tumors (cturbt) in a large multicenter retrospective cohort using propensity score-matched (psm) analysis.The psm cohort consisted of 202 patients: 101 in cturbt group and 101 in erbt group.Complications were detected in six patients in the cturbt group and four patients in the erbt group.The 3-year rfs estimates were 59.3% [95% confidence interval (ci) 48.2¿68.8] in the cturbt group, and 65.8% (95% ci 54.0¿75.2) in the erbt group (p = 0.7).There were no differences in the 3-year mfs and the 3-year css estimates between the two groups.The detection rate for mm¿vp was significantly higher in patients who underwent erbt (cturbt: 77% versus erbt: 99%, p\0.001).Erbt improves the quality of resection and specimen, yielding less residue on retur and yielding superior histopathologic information such as substaging.Bladder perforation requiring prolonged urethral catheter insertion occurred in one patient in the erbt group in which the olympus bipolar turis needle system was used.Related patient identifiers: (b)(6); (b)(6); (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.This medwatch report is for patient identifier (b)(6).
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.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE
• Common Device Name: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17393606
• Report Number: 9610773-2023-01992
• Device Sequence Number: 16767678
• Product Code: FAS
• UDI-Device Identifier: 14042761030615
• UDI-Public: 14042761030615
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100275
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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: WA22355C
• 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: 06/26/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/15/2023
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN BIOPSY FORCEPS
• Outcome Attributed to Adverse Event: Other; Other
• Patient Sex: Unknown