MAUDE Adverse Event Report: RICHARD WOLF GMBH HYSAFE; GRASP. FORCEPS INSERT 5FR WL 340MM

Model Number	86426508
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a hysteroscopy biopsy, the healthcare physician was unable to take a sample of tissue or polyps using the instrument.There is no report of injury or unacceptable risks, however the planned procedure could not be completed since there was no back-up device.Later, the patient was referred to another healthcare physician.

• Brand Name: HYSAFE
• Common Device Name: GRASP. FORCEPS INSERT 5FR WL 340MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 23468859
• Report Number: 1418479-2025-00013
• Device Sequence Number: 8890474
• Product Code: OCZ
• UDI-Device Identifier: 04055207027790
• UDI-Public: 04055207027790
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/04/2025
• Report Date (Section F): 11/04/2025

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: 86426508
• Device Catalogue Number: 8642.6508
• Device Lot Number: 4500309024
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/27/2025
• Device Age: 5 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/04/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8083.001 / LOT# 4500274682HANDLE WITH PROTECTION
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/04/2025