MAUDE Adverse Event Report: STERIS DEUTSCHLAND GMBH V. MUELLER; JACOBSON MOSQUITO FORCEPS

Model Number	CH8610
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris made multiple attempts to contact the user facility to obtain additional information regarding the reported event and to have the jacobson mosquito forceps subject of the reported event returned for evaluation however, the user facility has not responded.The lot number for the forceps subject of the event was not provided in medwatch # (b)(4).A follow-up report will be submitted should additional information become available.No additional issues have been reported.Udi related data clarification - the lot/serial number is unknown; therefore, the applicable production identifiers were not included in the mdr.".
Event or Problem Description
The user facility reported via medwatch # (b)(4) "at the end of a pediatric hernia repair, the staff identified a forceps instrument had a broken tip.The surgeon was questioned and they were certain that they didn't use this specific forceps for the procedure and that it must have been that way before they started.To be safe, leadership asked the team to do an x-ray in which it came back with nothing left behind.".

• Brand Name: V. MUELLER
• Common Device Name: JACOBSON MOSQUITO 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 ; 4402597401
• MDR Report Key: 24980906
• Report Number: 3006554912-2026-00005
• Device Sequence Number: 18764599
• Product Code: DWS
• UDI-Device Identifier: 10885403035364
• UDI-Public: (01)10885403035364
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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: CH8610
• Device Catalogue Number: CH8610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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