MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLAMPING JAW, SMALL

Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Brain Injury (2219)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
During the neurosurgical intervention of colloid cyst excision by ventricular endoscopy, the endoscope is held by a metal arm fixed to the intervention table in order to free the surgeon's hand.At the end of the operation, the clamping jaw used to hold the endoscope broke, causing movement of the endoscope which was in the patient's brain, causing bleeding from the ependymal veins and reducing visibility for the end.Intervention.

• Brand Name: CLAMPING JAW, SMALL
• Common Device Name: CLAMPING JAW
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: christiane klaiber ; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 16747120
• Report Number: 2020550-2023-00079
• Device Sequence Number: 3365796
• Product Code: OCV
• UDI-Device Identifier: 04048551265222
• UDI-Public: 4048551265222
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K990334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown