MAUDE Adverse Event Report: RICHARD WOLF GMBH; FLEX. GRASP. FORCEPS 5FR WL 550MM

Model Number 8735.685

Device Problems Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/04/2022

Event Type  malfunction  

Manufacturer Narrative

Rwmic is submitting this report on behalf of the manufacturer richard wolf gmbh.During inspection of the gripper by cqe, it was determined that the tie rod is bent distally and proximally as a result of mechanical overload.The present 8735.685 flex.Grasp.Forceps 5fr wl 550mm has the batch identification 4500352415 and originates from the order production order of the same name, which was booked to the new goods warehouse with an order size of 15 pieces on (b)(6) 2022.These pliers are purchased as an oem product from bacher.The latter confirms with test report 640793 the testing of all 15 pieces without any abnormalities.These forceps were delivered to the customer on (b)(6) 2022 with delivery bill 82087277.The cause of failure of the distally/proximally bent pull rod are due to customer fault as a result of mechanical overload.The user's attention is drawn to the limited stability of the products in section 10 of ga-s004.Excessive forces will damage the product and impair its function.In general, the user is advised in the associated instructions for use ga-s004 under chapter 8 that a visual and functional check must be carried out before and after each use, as well as during reprocessing.Possible damage of the above type can be easily detected by the personnel if these instructions are followed.In our risk analysis b1-2 rev.05, manufacturing-related, handling-related and design-related hazards with regard to a functional impairment as well as risks due to an unusable product with the corresponding extent of damage and the assumed probability of occurrence were considered and assessed with an acceptable risk.As no new risks have arisen from the investigation of the current case, the risk assessment remains valid in view of the facts described.No comparable case of this type 8735.685 with "pull rod bent distally/proximally - mechanical overload" has been registered in the period under review.The inspection of the gripper did not reveal any systematic defects from a manufacturing or design point of view.With regard to the damage described above, the customer is at fault due to mechanical overload.No measures are required with regard to the findings obtained.Richard wolf gmbh (rwgmbh) considers this matter closed.However, in the event rwgmbh receives any additional information a follow up report will be submitted to fda.

Event Description

Richard wolf gmbh complaint reference (b)(4).It was reported to richard wolf gmbh.(rwgmbh) that "when trying to remove a dj splint(catheter), the forceps could no longer be turned or opened.The operation was aborted.The patient did not suffer any consequences." rwgmbh awareness date, (b)(6) 2022.

• Type of Device: FLEX. GRASP. FORCEPS 5FR WL 550MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; 75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• MDR Report Key: 15058126
• MDR Text Key: 304710186
• Report Number: 9611102-2022-00036
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 04055207020265
• UDI-Public: 04055207020265
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 07/19/2022

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?: Yes
• Device Operator: Other
• Device Model Number: 8735.685
• Device Catalogue Number: 8735.685
• Device Lot Number: 4500352415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2022
• Initial Date FDA Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other