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

Model Number	27093LL-S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned for evaluation; however, our sales representative viewed the device and also provided a picture, which shows three pieces were broken off of the oscillating probe tip.The hospital confirmed that the broken pieces were retrieved and there was no harm to patient.In addition, we learned from the hospital that the kidney stone was very hard and that after the surgeon had been working on it for some time using this probe, the ultrasonic calcuson unit displayed a warning light; he continued using the probe and the tip eventually broke.It is possible the warning light was the transducer fault indicator - resonance warning, which can indicate either a damaged probe or transducer.A possible root cause of this type of breakage is overheating and/or mechanical overload.Both are user related issues and are addressed in our ifu.
Event or Problem Description
Allegedly, during a percutaneous nephrolitomy procedure, three pieces of tip of the ultrasonic probe broke off into the patient.The broken pieces were retrieved and procedure was completed using a different probe.Hospital confirmed there was no injury to patient.

• Brand Name: OSCILLATING ULTRASONIC PROBE
• Common Device Name: OSCILLATING ULTRASONIC PROBE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 8096620
• Report Number: 9610617-2018-00091
• Device Sequence Number: 11099197
• Product Code: FEO
• UDI-Device Identifier: 04048551394182
• UDI-Public: 4048551394182
• 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: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/23/2018

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: 27093LL-S
• Device Catalogue Number: 27093LL-S
• Device Lot Number: ST01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/21/2018
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 102