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
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.".
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 rwmic complaint id: (b)(4).
Additional Manufacturer Narrative
This follow-up report is in response to a request received by richard wolf gmbh from a fda (mdr data system team) regarding a related report information that was not included in the corresponding block h10 of medwatch form 3500a.
Additional Manufacturer Narrative
The following fields have new information: b4, g3, g6, h2, h6 (type of investigation, investigation findings, and investigation conclusions), h7, and h11.The user facility did not return the laser guide tube hence, unable to evaluate interaction between guide tube and the working element.Richard wolf medical instruments corporation (rwmic) investigated the reported issue and determined that the end of the laser guide locking screw is worn down.The probable root cause is "wear on the lock screw".It is a common issue when a laser working element is heavily used due to the frequent metal-on-metal friction between the screw and the laser guide.The working element passive bipo 0/12/30°, part id: 8654.282, was manufactured on 20/feb/2023.The batch# 1539630 consisted of 17 pieces.One piece did not meet the inspection specification and was scraped.No further complaints were received from the reported batch.The instructions for use, ifu ga-d333 / us / 2014-06 v2.0 / eco 2014-0194 contains several safety instructions, warnings, and information regarding "loose or damage parts" in section 9 checks.The subject issue of the lesion is present in the risk management file b6: reusable optical inserts, v00.The overall probability of occurrence for this issue remains at previously defined levels and overall risk of the device remains in the acceptable category.

• Common Device Name: LASER WORKING ELEMENT PASSIVE 12/30°
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: valentin felsing ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 20427156
• Report Number: 9611102-2024-00035
• Device Sequence Number: 8441334
• Product Code: FDC
• UDI-Device Identifier: 04055207018781
• UDI-Public: 04055207018781
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K980302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 10/15/2024; 11/05/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 10/16/2024; 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male