MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OUTER SHEATH, 26 FR., 2 STOPCOCKS, VERTICAL, FIXED; RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS

Model Number	A22027A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyponatremia (4494); Urethral Stenosis/Stricture (4501); Urinary Incontinence (4572)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the evaluation was performed exclusively on the basis of the available information.No device malfunction was reported in the study.Therefore, the suspect medical device is assumed to be meeting its specification.Based on the information available, the exact cause of the reported phenomena and the patients¿ outcome could not be determined and is being judged as unknown.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing.The case will be closed on olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes.
Event or Problem Description
Olympus received a study titled ¿monopolar transurethral resection of the prostate versus holmium laser enucleation in men with prostate volume greater than 100 ml¿.This retrospective study was aimed to compare the safety and efficacy of monopolar transurethral resection of the prostate (m-turp) and holmium laser enucleation of the prostate (holep) for prostate size >100 ml.Thirteen patients underwent m-turp (group 1), and 27 underwent holep (group 2).There were more complications in group 1 than group 2, especially for patients undergoing transfusion and with hyponatremia (2 in group 1 and 0 in group 2).At 3-month follow-up, the international prostate symptom score, quality of life score, and residual urine volume revealed no significant differences between groups.This study concluded that m-turp and holep in men with prostate volume greater 100ml had similar operative time, admission days and postoperative functional outcomes.However, higher transfusion rates and postoperative hyponatremia were noted in the m-turp group comparing to the holep group.The model number of the product (26-fr resectoscope) was unknown, but a representative product (a22027a) was chosen for processing purposes.No device malfunction was reported in the literature.Type of adverse events/number of patients: blood transfusion - 6 patients.Recatheterization - 4 patients.Urethral stricture - 1 patient.Urge urinary incontinence - 7 patients.

• Brand Name: OUTER SHEATH, 26 FR., 2 STOPCOCKS, VERTICAL, FIXED
• Common Device Name: RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 15400848
• Report Number: 9610773-2022-00389
• Device Sequence Number: 6464038
• Product Code: GCP
• UDI-Device Identifier: 04042761029353
• UDI-Public: 04042761029353
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2022

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: A22027A
• Device Catalogue Number: A22027A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 09/12/2022
• 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: CONMED SYSTEM 5000 ELECTROSURGICAL UNIT; UNSPECIFIED STORZ NEPHROSCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male