MAUDE Adverse Event Report: W&H DENTALWERK BÜRMOOS GMBH S-11 SURGICAL HANDPIECE; HAND PIECE

Model Number	S-11
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Root cause and conclusions: after investigation the course of the accident could not be reconstructed in any way.The handpiece was heavily soiled and damaged.The described adverse event is a case of lack of maintenance and a user error.
Event or Problem Description
In preparation for the operation, a functional test of an elan electric motor from aesculap with an s-11 handpiece from w&h was carried out.The "tip" (front part) of the handpiece came loose and caused an injury to the eye of a surgical nurse.

• Brand Name: S-11 SURGICAL HANDPIECE
• Common Device Name: HAND PIECE
• Manufacturer (Section D): W&H DENTALWERK BÜRMOOS GMBH; ignaz-glaser strasse 53; buermoss, 5111 ; AU 5111
• Manufacturer (Section G): W&H DENTALWERK BÜRMOOS GMBH,; ignaz-glaser strasse 53; buermoos, 5111 ; AU 5111
• Manufacturer Contact: gerhard weidler ; ignaz-glaser strasse 53; buermoos, 5111 ; AU 5111
• MDR Report Key: 19189749
• Report Number: 3011300255-2024-00002
• Device Sequence Number: 8474252
• Product Code: EGS
• UDI-Device Identifier: J021000011001
• UDI-Public: +J021000011001
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K011061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2024

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: S-11
• Device Catalogue Number: 00001100
• 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: 04/02/2024
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2012
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown