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  

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.

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).

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).

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
• 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: 16940967
• MDR Text Key: 315319664
• Report Number: 9610617-2023-00079
• 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,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/16/2023
• Supplement Dates Manufacturer Received: 04/19/2023; 06/14/2023
• Supplement Dates FDA Received: 05/16/2023; 06/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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