MAUDE Adverse Event Report: W&H DENTALWERK BÜRMOOS GMBH WS-91 LG SURGICAL CONTRA-ANGLE HANDPIECE

Model Number WS-91 LG

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 09/11/2023

Event Type  Injury  

Manufacturer Narrative

Findings and root cause analysis: handpiece full of dried dark brown debris/deposits, seized.Complete head shell affected.Head gear and front middle gear damaged.Conclusions: burning caused through lack of and/or insufficient maintenance; not maintained as recommended in the instructions for use.

Event Description

Customer complaint via e-mail: this particular unit burned a patient's cheek pretty bad.

• Brand Name: WS-91 LG SURGICAL CONTRA-ANGLE HANDPIECE
• Type of Device: SURGICAL CONTRA-ANGLE HANDPIECE
• Manufacturer (Section D): W&H DENTALWERK BÜRMOOS GMBH; ignaz-glaser-strasse 53; buermoos, 5111 ; AU 5111
• Manufacturer (Section G): W&H DENTALWERK BÜRMOOS GMBH; ignaz-glaser-strasse 53; buermoos, 5111 ; AU 5111
• Manufacturer Contact: gerhard gerhard ; werner bader strasse 1; buermoos, 5111 ; AU 5111
• MDR Report Key: 17787717
• MDR Text Key: 323908301
• Report Number: 3011300255-2023-00006
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080939
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WS-91 LG
• Device Catalogue Number: 30048000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2022
• 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