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
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.
Additional Manufacturer Narrative
*this report was incorrectly filed under the importer mfr number - 2020550-2023-00079.The report was filed within the fda filing timeline.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).
Additional Manufacturer Narrative
During the investigation of the claimed article, a breakage of the holding arm could be detected, which is probably due to a reprocessing error or the resulting corrosion.Dark spots are visible from where the corrosion and the resulting weakening of the material could spread.In addition, impurities are visible, which probably caused micro cracks.According to the date of manufacture (02.2018), the article is 5 years old, during which time the cracks were able to spread and finally break.The ifu, therefore, points out that the articles should be checked for defects and damage before use.The event is filed under internal karl storz complaint (b)(4).
Additional Manufacturer Narrative
The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).

• 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: 16940967
• Report Number: 9610617-2023-00079
• Device Sequence Number: 7562357
• 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,Followup,Followup
• Report Date (Section B): 06/16/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 04/19/2023; 06/14/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 05/16/2023; 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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