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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Brain Injury (2219)

Event Date 02/27/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 313387813
• Report Number: 2020550-2023-00079
• Device Sequence Number: 1
• Product Code: OCV
• UDI-Device Identifier: 04048551265222
• UDI-Public: 4048551265222
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K990334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention