MAUDE Adverse Event Report: KARL STORZ SE & CO. KG STONE EXTRACTOR, 0.6MM STERILE; SALIVARY STONE EXTRACTOR

Model Number	11575L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received no further details of the event, and no evaluation report has been received from the manufacturer as of yet.
Event or Problem Description
As per a copy of an initial mir we received from the factory in (b)(4): product broke during use.

• Brand Name: STONE EXTRACTOR, 0.6MM STERILE
• Common Device Name: SALIVARY STONE EXTRACTOR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 10532167
• Report Number: 9610617-2020-00100
• Device Sequence Number: 3143719
• Product Code: GCJ
• UDI-Device Identifier: 04048551051689
• UDI-Public: 4048551051689
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K012527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2020

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 Expiration Date: 11/28/2024
• Device Model Number: 11575L
• Device Catalogue Number: 11575L
• Device Lot Number: 21463
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other