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

Model Number S-11

Device Problem Use of Device Problem (1670)

Patient Problem Eye Injury (1845)

Event Date 02/21/2024

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 341118132
• Report Number: 3011300255-2024-00002
• Device Sequence Number: 1
• Product Code: EGS
• UDI-Device Identifier: J021000011001
• UDI-Public: +J021000011001
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K011061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: S-11
• Device Catalogue Number: 00001100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other