MAUDE Adverse Event Report: KARL STORZ SE & CO. KG PROBE, 4 MM, 12 CM; ARTHROSCOPIC PROBE

Model Number	28145W
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No investigation possible so far - product not yet returned.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(6): breakage of the instrument tip during surgery.Operation extension of 30 min.
Additional Manufacturer Narrative
Data in section h6 have been corrected to match the evaluation findings.
Additional Manufacturer Narrative
The instrument was returned on 03 february 2021 for investigation.Upon evaluation, it can be confirmed that the distal part of the instrument was broken.The instrument was heavily bent which indicated high force applied.There is no sign of corrosion.The root cause is most likely mechanical overload i.E user error.The instrument was manufactured in 2005.No indication for a material or manufacturing related issue was found during the investigation.Based on the evaluation, this case is user error or product abuse without patient harm, therefore a non-reportable incident.

• Brand Name: PROBE, 4 MM, 12 CM
• Common Device Name: ARTHROSCOPIC 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 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 11151361
• Report Number: 9610617-2021-00004
• Device Sequence Number: 3920296
• Product Code: LXH
• UDI-Device Identifier: 04048551095607
• UDI-Public: 4048551095607
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2022

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: 28145W
• Device Catalogue Number: 28145W
• Device Lot Number: BE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 12/22/2020; 08/10/2022
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 08/09/2022; 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2005
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown