MAUDE Adverse Event Report: SCHOELLY FIBEROPTIC GMBH None; Camera Control Unit

Model Number	470653-01
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction

• Brand Name: None
• Common Device Name: Camera Control Unit
• Manufacturer (Section D): SCHOELLY FIBEROPTIC GMBH; robert-bosch-strasse 1-3; denzlingen 79211 ; GM 79211
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; +1(408)523-2100
• MDR Report Key: 50724504
• Report Number: 2955842-2026-38206
• Device Sequence Number: 8542345
• Product Code: GCJ
• UDI-Device Identifier: 04250480109083
• UDI-Public: (01)04250480109083
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K221591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other,Notification
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 470653-01
• Device Catalogue Number: 470653
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: ISIFA2026-03-C
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 167 LB