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

Model Number 27093LK

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Date 02/12/2019

Event Type  malfunction  

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 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
• Type of Device: OSCILLATING STERILE PROBE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; 2151 east grand avenue; el segundo, CA 90245-5017
• MDR Report Key: 8538148
• MDR Text Key: 142770141
• Report Number: 9610617-2019-00039
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 04048551395073
• UDI-Public: 4048551395073
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K843101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 27093LK
• Device Lot Number: 51791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/22/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other