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.
Additional Manufacturer Narrative
Investigation results: the grasp.Forceps insert 5fr wl 340 mm, 8642.6508, lot#4500309024 was investigated by the responsible department, and the reported condition was confirmed.The tips of forceps do not actuate.Proximal end of forceps insert pull-rod were broken off.The shaft of the insert is severely bent.During the inspection, the handle (concomitant device) part id: 8083.001, lot# 4500274682 was also evaluated and found to have met the specifications.Probable root cause: the probable root cause for the reported issue was determined to be user error.The proximal end of the pullrod was damaged and broken due to excessive force on the device.The user attempts to disconnect the insert from the handle without properly disengaging the lock that holds it in place.The bends in the shaft are the result of pulling the forceps from a working channel at an angle and/or with excessive force.Section 9 of ga-s016 / en-us / 2015-03 v2.0 cautions the limited strength of the device and the potential damage that can occur from excessive forces.Manufacturing analysis: the grasp.Forceps insert 5fr wl 340 mm, type 8642.6508 with batch number 4500309024 was manufactured on august 31, 2020.The batch size was (b)(4) pieces, and no special approvals or other anomalies were reported.Historical data analysis: on november 11, 2020, 43 pieces were shipped to rwmic, and on january 21, 2021, 1 peace was sent to progressive women's health.A search of the complaints database revealed no further complaints about this batch.In addition, (b)(4) pieces were sold between november 17, 2020, and january 11, 2021, with no further complaints received.In our risk analysis (b)(4), manufacturing-related, handling-related, and design-related hazards relating to functional impairment, as well as risks posed by an unusable product, were considered with the corresponding extent of damage and assumed probability of occurrence and were assessed as an acceptable risk.

• Brand Name: HYSAFE
• Common Device Name: GRASP. FORCEPS INSERT 5FR WL 340MM
• 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: 23468874
• Report Number: 9611102-2025-00058
• Device Sequence Number: 8919245
• Product Code: OCZ
• UDI-Device Identifier: 04055207027790
• UDI-Public: 04055207027790
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051276
• 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): 02/24/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2020
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8083.001 / LOT# 4500274682.HANDLE WITH PROTECTION.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown