MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ELECTROSURGICAL UNIT

Model Number	UES-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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) reviewed the following literature titled "efficacy and safety of ultrasonography guided transperineal percutaneous laser ablation for treating benign prostatic hyperplasia: a randomized controlled clinical trial compared with transurethral resection of the prostate".Literature summary introduction & objectives: to evaluate the efficacy and safety of tpla treatment by randomized controlled trial (rct), comparing that of turp and to provide convincing evidence for its clinical application.Materials & methods: bph patients between 6/2019 to 12/2021, with qmax=15 ml/s and ipss =8 were included and randomly assigned to turp or tpla group at 1:1, the follow-up was conducted at 1, 3, 6, and 12 months after the operation.Interventions: tpla was conducted with esaote mylab twice equipped with flexible optical fiber, and turp was performed by olympus ues-40 surgmaster system under standard procedure.The primary efficacy endpoint was the ipss score variation at 3 months from baseline.The primary safety endpoint was the incidence of complications within 3 months after treatment.We also compared the qmax, qol score, mshq-ejd score, blood loss, and catheter indwelling time between the groups.Variables were compared by t-test, wilcoxon test, or fisher's exact test accordingly.Results: the ipss decreased by 14.17±6.13 at 3 months after tpla, and by 13.19±5.86 after turp (p=0.706).The complication rate of tpla and turp was 16% and 19.23% respectively (p=0.811).Tpla proved less intraoperative blood loss (6.84±3.1ml, p<0.001) and better ejaculatory protection within 6 months (p<0.05).Turp has advantages in catheter indwelling time (p=0.012) and qmax within 6 months (p<0.05).Conclusions: this randomized controlled clinical trial between tpla and turp confirms that tpla is not inferior to turp in relieving symptoms of bph.Turp has more advantages in the improvement of qmax and tpla exceeds in preserving ejaculation within 6 months.In addition, tpla has shorter operation time and hospitalization time, less blood loss and pain, and may be more suitable for elderly patients who are unwilling or unable to tolerate turp, or for those with anemia and other basic diseases.
Event or Problem Description
It was reported by the author that an olympus device did not cause or contribute to the adverse events described in the article.Also, it was confirmed that there was no malfunction of an olympus device.
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 additional information received from the author.B5 updated accordingly.Also, a correction has been made to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: ELECTROSURGICAL UNIT
• Common Device Name: ELECTROSURGICAL UNIT
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19370731
• Report Number: 3002808148-2024-04658
• Device Sequence Number: 20714872
• Product Code: GEI
• UDI-Device Identifier: 04953170165429
• UDI-Public: 04953170165429
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2024

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: UES-40
• 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: 05/07/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 05/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown