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	Micturition Urgency (1871); Urinary Retention (2119); Urinary Tract Infection (2120); Hematuria (2558); Erectile Dysfunction (4511); Unspecified Reproductive System or Breast Problem (4513); Urinary Incontinence (4572)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned.Attempts were performed to obtain additional information, but no response was received.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
Olympus reviewed the following literature titled "two-year follow-up comparing rezum therapy versus bipolar transurethral resection of the prostate for treating benign prostatic hyperplasia.A prospective randomized study".Literature summary: objective: comparison of the efficacy and safety of realm therapy and bipolar transurethral resection of prostate (b-turp) for the management of benign prostatic hyperplasia (bph) of 50-120 g size.Methods: one hundred patients with bph who met the inclusion criteria were included and split into two equal groups to undergo rezum therapy or b-turp.The two groups were compared for efficacy using international prostate symptom score (ipss), quality of life (q00, maximum urinary flow rate (qmax), operative time, catheter time, hospital stay, post-void residual urine (pvr), prostate-specific antigen (psa), and residual prostate size and safety using the incidence of complications.Results: rezum significantly ameliorated ipss from the baseline score by 55.3%, qol by 50%, qmax by 62.5%, international index of erectile function (iief) by 7.1%, pvr by 50%, residual prostate size by 28.1% and psa by 42% at 2 years.Meanwhile, the improvement in b-turp was significantly higher than rezum group, rezum therapy had a significantly shorter duration of operative time and hospital stay.Also, it had fewer complications in comparison with b-turp.Conclusions: rezum is a minimally invasive procedure that provides significantly improved symptomatic relief of bph and quality of life with preservation of erectile and ejaculatory functions.However, it is not as effective as b-turp.The following events have been reported in the literature: postoperative ed (46 cases), hematuria (5 cases), uti (5 cases), urine retention (1 case), retrograde ejaculation (29 cases), incontinence-urgency (3 cases), retreatment was done by the same previous procedure (2 cases).
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.However, 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: 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: 19934625
• Report Number: 3002808148-2024-07415
• Device Sequence Number: 12616146
• Product Code: GEI
• UDI-Device Identifier: 04953170165429
• UDI-Public: 04953170165429
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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: Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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: 07/11/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 10/16/2024
• 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: Required Intervention
• Patient Sex: Male