MAUDE Adverse Event Report: KARL STORZ SE & CO. KG PROBE,STERILE, ULTRASONIC OSCILLATING; OSCILLATING STERILE PROBE

Model Number	27093LK
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer has not returned product 27093lk and has not responded to our attempts to gather further information.The sterile ultrasonic oscillating probe was shipped to the customer approximately 3 years ago.
Event or Problem Description
Allegedly, the item broke in two pieces in the patient during a procedure.They were able to retrieve all broken pieces and it was reported there was no harm to the patient.

• Brand Name: PROBE,STERILE, ULTRASONIC OSCILLATING
• Common Device Name: OSCILLATING STERILE PROBE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 8538148
• Report Number: 9610617-2019-00039
• Device Sequence Number: 2458553
• Product Code: FEO
• UDI-Device Identifier: 04048551395073
• UDI-Public: 4048551395073
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K843101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2019

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 Model Number: 27093LK
• Device Lot Number: 51791
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/22/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other