MAUDE Adverse Event Report: KARL STORZ SE & CO. KG DCI HOPKINS TELESCOPE; HOPKINS 30 DEGREE DCI SCOPE

Model Number	10970BA
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation on-going.Product has been returned but the evaluation is not complete.Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted unsolicited.The event is filed under internal karl storz complaint id (b)(4).As of today, there is one similar device report or a report due to similar complaint assessment.Per the ifu im-000003 ifu v17.0 states to inspect the endoscope for any visible signs of damage and to not use if it is damaged or difficult to use.
Event or Problem Description
It was reported that there was event with a 10970ba dci hopkins telescope 30 degree.During assembly of the three-part mediastinoscope, the scope broke off from its base.Surgery was canceled.No patient injury, patient under anesthesia, but no incision made.
Additional Manufacturer Narrative
During assembly of the mediastinoscope with the combination products, the shaft broke at the connection point to the base body.The examination did not reveal any impairment or weak point at the connection point between the shaft and the base body (laser weld).The breakage was caused by a high force impact, which led to a total failure of the optics.The breakage is based on user error and is not due to a production or manufacturing defect.At the time of the failure, the optic was already > 9 years old.Pre-damage in the area of the connection point cannot be ruled out due to the age.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: DCI HOPKINS TELESCOPE
• Common Device Name: HOPKINS 30 DEGREE DCI SCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 16827330
• Report Number: 9610617-2023-00087
• Device Sequence Number: 7125208
• Product Code: GCJ
• UDI-Device Identifier: 04048551049556
• UDI-Public: 4048551049556
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K983363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2023

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: 10970BA
• Device Catalogue Number: 10970BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2006
• 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
• Patient Sex: Unknown