MAUDE Adverse Event Report: KARL STORZ IMAGING ASM,HEAD,IMAGE1 S,H3-Z, CE

Model Number	TH100
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Correction to the faulty product.
Additional Manufacturer Narrative
*correction to section d.1, d.2, d.3, d.4 and g.4.The correct routing number should have been (b)(4).Since the initial mdr was filed with 9610617-2026-01825 we will continue on using it for additional supplemental that will be created for this mdr.Information reflected in section d-3 and g-1.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ASM,HEAD,IMAGE1 S,H3-Z, CE
• Common Device Name: ASM,HEAD,IMAGE1 S,H3-Z, CE
• Manufacturer (Section D): KARL STORZ IMAGING; 1 s. los cameros road; goleta CA 93117
• Manufacturer (Section G): KARL STORZ IMAGING; 1 s. los cameros road; goleta CA 93117
• Manufacturer Contact: theresa mussaw ; 2151 e grand ave; el segundo, CA 90245 ; +1(410)441-1327
• MDR Report Key: 50499305
• Report Number: 2027009-2026-01825
• Device Sequence Number: 21194951
• Product Code: FET
• UDI-Device Identifier: 04048551333136
• UDI-Public: 04048551333136
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K131953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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: TH100
• Device Catalogue Number: TH100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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