MAUDE Adverse Event Report: RICHARD WOLF GMBH PIRANHA; ROTATIONS-MORCELLATOR Ø 4.8MM WL 335MM

Model Number	49700113
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Richard wolf gmbh has been informed of an issue regarding a rotations-morcellator ø 4.8mm wl 335mm, part id: 49700113, lot# unknown.According to the received information, a holmium laser enucleation of the prostate (holep) procedure and morcellation was planned.For this purpose, a power control 2303 (richard wolf), piranha control 2208 (richard wolf), piranha handpiece (richard wolf) and a holep nephroscope system from karl storz was provided in the operating theatre.When using the holep nephroscope system from karl storz, the piranha blade vmax rotary morcellator 49700103 (richard wolf) must be used.Instead, a richard wolf instruments, piranha blade vmax rotation morcellator, 49700113 were supplied.The richard wolf blade supplied is not compatible for karl storz instruments.The enucleation was completed.However, the morcellation was unable to be completed, because the incorrect size morcellator blade (49700113) was applied.There was no reported harm to the patient.The procedure was completed 10-days later under a second general anesthetic surgery.
Additional Manufacturer Narrative
New information: b4, d9, g3, g6, h2, h6 (type of investigation, investigation findings, investigation conclusions), h8, and h10.The user had planned an application using the holep nephroscope system from karl storz.During the application, the user realized that the rotations-morcellator ø 4.8mm wl 335mm, part id: 49700113 provided to him were not compatible for use with the storz equipment.He could only use the rotations-morcellator ø 4.8mm wl 385mm, 49700103.As a result, the operation had to be cancelled at this point and completed 10 days later in a new operation.In the instructions for use ga-a2o2 / en / v13.0 / 2023-08 / pk23-0005, the user is informed about the following relevant points: chapter 2.5 (indications and field of use) - in urology for the fragmentation and the removal of detached prostatic adenomas after laser turp.Caution: in therapeutic applications, an adequate backup device with the same capabilities must be available should the device fail.Chapter 2.7 (general notes and instructions for use) warning: this product must only be applied in combination with the devices approved by richard wolf and following the corresponding device instruction manual.Caution: incorrect combination of products! injury may result to the patient, user, or others, and damage may result to the product.The different products may only be combined if the intended use and the relevant technical data (working length, diameter, etc.) are the same.The instructions for use of the products used in the product combination must be observed.Chapter 2.8 (combinations) attention: in addition to this instruction manual, follow the manuals for the products used in combination with this product.If other products are used in combination with this product, make sure that the intended uses and relevant technical data (working length, diameter, etc.) are the same.Use only approved components and connection cables.The only difference between the two rotations-morcellator ø 4.8mm wl 385mm, 49700103 and rotations-morcellator ø 4.8mm wl 335mm, 49700113 is the effective length.When using richard wolf products, the rotations-morcellator ø 4.8mm wl 385mm, 49700103 must be used.In this case, it was discovered immediately before using the rotary morcellator that it was 50 mm too short.In the period from (b)(6) 2010 to (b)(6) 2024, there were no other similar complaints about the two types (b)(4).In summary, there is no recognizable product or manufacturing defect.The dimensional differences are significant at 50 mm and have not led to any further confusion in the past.The wrong morcellator was provided during the surgical preparation.We therefore assess the case as a user error with the consequence of a further unplanned operation for the patient.

• Brand Name: PIRANHA
• Common Device Name: ROTATIONS-MORCELLATOR Ø 4.8MM WL 335MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 19773010
• Report Number: 9611102-2024-00025
• Device Sequence Number: 18159737
• Product Code: FJL
• UDI-Device Identifier: 04055207063422
• UDI-Public: 04055207063422
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K041610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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: 49700113
• Device Catalogue Number: 49700113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2208001, SUCTION PUMP (RICHARD WOLF); 2303.001, MOTOR CONTROL UNIT 2303 (RICHARD WOLF); 8564.121/122, PIRANHA HANDPIECE (RICHARD WOLF); HOLEP NEPHROSCOPE SYSTEM (KARL STORZ)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown