MAUDE Adverse Event Report: RICHARD WOLF GMBH ENDOCAM; LOGIC 4K CAMERA HEAD

Model Number	85525942
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The logic 4k camera head, part id: 85525942, s/n # (b)(6) comes from production batch 1521359.The batch consists of 15 logic 4k camera head.As of (b)(3) 2023, we have not received any further complaints about this batch.
Event or Problem Description
A distributor has informed richard wolf gmbh (rwgmbh) of an issue regarding a logic 4k camera head, part id: 85525942, s/n # (b)(6).According to the received information, when setting up the equipment for the endoscopic spine surgery the staff noticed that the camera head was not visible and registered by the video processor.Mta and service technician from richard wolf did a search for the error but did not manage to get the camera head to work at all.As the patient was already ready for the surgery, the surgeon took the decision to switch to open surgery instead of planned endoscopic surgery.

• Brand Name: ENDOCAM
• Common Device Name: LOGIC 4K CAMERA HEAD
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 18386255
• Report Number: 9611102-2023-00076
• Device Sequence Number: 11431693
• Product Code: FET
• UDI-Device Identifier: 04055207063163
• UDI-Public: 04055207063163
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K180583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 85525942
• Device Catalogue Number: 85525942
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown