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

Model Number	TH104
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The previous reportability decision for this event was reversed based on a retrospective review.The main issue causes were determined as contamination on the card edge leading to intermittent connections with the ccu receptacle, cable worn-out card edge, worn cable, and uneven wear in the optical assembly.The event is filed under internal karl storz complaint id:(b)(4).
Event or Problem Description
It was reported loss of image during procedures.Procedures could be completed in three cases, either using a backup unit or the same device and no harm occurred to the patients, users or third parties.In one case, no further information regarding the outcome of the procedure could be obtained after multiple request attempts.However, it is unlikely that this would cause patient injury or death as facilities routinely have back up video equipment that could be used to complete the procedure.
Additional Manufacturer Narrative
Udi related data quality updates only: the initial mdr had the correct udi number but the first digit "0" was omitted.Please see section d4 of this mdr form for the updated udi number.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ASM,HEAD,IMAGE1 S,H3-ZA, CE
• Common Device Name: HEAD, IMAGE
• Manufacturer (Section D): KARL STORZ IMAGING; 1 s. los carneros road; goleta CA 93117
• Manufacturer (Section G): KARL STORZ IMAGING; 1 s. los carneros road; goleta CA
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 17962230
• Report Number: 2027009-2023-00296
• Device Sequence Number: 17821499
• Product Code: FET
• UDI-Device Identifier: 04048551333969
• UDI-Public: 04048551333969
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K131953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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: TH104
• Device Catalogue Number: TH104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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