MAUDE Adverse Event Report: RICHARD WOLF GMBH; LASER WORKING INSERT 12/30 7.5FR

Model Number	8654911
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a laser enucleation of the prostate, the surgeon mentioned that the laser bridge was loose.She continued the case and approximately 10-15 minutes into lasering, the laser working channel broke off into her hand.The sterile processing department (spd) was able to immediate-use steam sterilization (iuss) with another device and the case resumed without incident.Although no injuries were reported and the planned procedure could be completed with a back-up device, there was a delay of half an hour.
Additional Manufacturer Narrative
Investigation results: the device was investigated and the reported condition was confirmed.The proximal laser guide tube is broken off where it joins the connecting housing for the scope and irrigation channels.Additionally, the sheath has minor dents and scratches that do not affect the function and are not unusual for a 10 year old instrument.Probable root cause: the probable root cause was determined to be a user error.The ragged edge of metal at the break, rather than the solder holding the tube in place, suggests repeated excessive force on the metal, either twisting or flexing.When looseness was noted, the device should have been immediately rejected and sent for repair.Section 7 of instruction for user (ifu), ga-d278 cautions the user on the limited strength of the device and the potential damage that can occur from excessive forces.Section 8 of the ifu, ga-d278 cautions the user not to use products which are damaged.Manufacturing analysis: the laser working insert 12/30 7.5fr, 8654.911, with lot number: 1291136, was manufactured on september 7, 2015.The lot consists of (b)(4) units.The entire batch was sold between january and august 2016.Historical data analysis: since delivery to richard wolf medical instruments corporation (rwmic) or other customers, two additional complaints regarding this batch have been received; however, these were due to other defects.Otherwise, no further complaints have been received.Risk assessment analysis: the subject issue of functional malfunction/loss of function due to an unusable product 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.The risk profile remains unchanged.

• Common Device Name: LASER WORKING INSERT 12/30 7.5FR
• 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: anja ehrenfeuchter ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 23404871
• Report Number: 9611102-2025-00057
• Device Sequence Number: 9047014
• Product Code: FJL
• UDI-Device Identifier: 04055207018835
• UDI-Public: 04055207018835
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 8654911
• Device Catalogue Number: 8654.911
• Device Lot Number: 1291136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Unknown