MAUDE Adverse Event Report: STERIS Deutschland GmBh V. Mueller; Tenaculum Forceps

Model Number	GL850
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2026
Type of Reportable Event	Malfunction

• Brand Name: V. Mueller
• Common Device Name: Tenaculum Forceps
• Manufacturer (Section D): STERIS Deutschland GmBh; kantstrasse 33/1; wurmlingen baden-wurttemberg D-785 73; GM D-78573
• Manufacturer (Section G): STERIS Deutschland GmBh; kantstrasse 33/1; wurmlingen baden-wurttemberg D-785 73; GM D-78573
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; +1(440)259-7401
• MDR Report Key: 50938594
• Report Number: 3006554912-2026-00009
• Device Sequence Number: 13445473
• Product Code: HCZ
• UDI-Device Identifier: 10885403043703
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2026

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: Health Professional
• Device Model Number: GL850
• Device Catalogue Number: GL850
• Device Lot Number: (10)XFAV10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 09/29/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown