MAUDE Adverse Event Report: RICHARD WOLF GMBH; LASER WORKING ELEMENT PASSIVE 12/30°

Model Number	8654282
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Needle Stick/Puncture (2462)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been received by richard wolf medical instruments corporation (rwmic) and device investigations are in progress.The event is filed under (b)(4) complaint id: (b)(4).Related report number: (b)(4).
Event or Problem Description
It was reported that during a cystoscopy and holep procedure, "it was noted that the long metal laser bridge had become separated from the remainder of the hand piece of the laser working element.It was identified immediately, and the laser metal bridge was able to be removed intact.There was no part of the instrument that was retained.There was a small defect noted in the posterior wall of the bladder that was presumed to be from the tip of the laser bridge that had become detached.The defect was less than 0.5cm which was inspected with a cystogram and repaired." "a 3-way foley was placed with continuous bladder irrigation infusing.The patient tolerated the procedure well without significant blood loss and was transferred to recovery in stable condition.The patient was discharged home with the foley catheter in place and follow-up scheduled with the urology office.".

• Common Device Name: LASER WORKING ELEMENT PASSIVE 12/30°
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 20427024
• Report Number: 1418479-2024-00009
• Device Sequence Number: 7860667
• Product Code: FDC
• UDI-Device Identifier: 04055207018781
• UDI-Public: 04055207018781
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/11/2024
• Report Date (Section F): 10/11/2024

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
• Device Model Number: 8654282
• Device Catalogue Number: 8654.282
• Device Lot Number: 1539630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/16/2024
• Device Age: 20 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Date Report Sent to FDA: 10/11/2024