MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TIPCAM 1 S 3D LAP, 0°

Model Number 26605AA

Device Problem Optical Problem (3001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2024

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).

Event Description

It was reported that the device started flickering during use which cause a delay of 15 to 60 mins.Furthermore, according to the information received, the procedure could not be completed successfully, since the final inspection of the operating area could not take place.

Manufacturer Narrative

The information provided by the customer can be confirmed, no connection can be made between the tipcam we have and our camera unit.Further examination of the tipcam revealed impact marks and scratches on the shaft.The scratches are due to normal use.The impact marks were caused by external mechanical damage.Furthermore, impact marks and scratches can be seen at the distal end and in the edge area of the distal lenses.The connecting cable is visibly deformed around the handle, which indicates a cable break or damage to the individual cable strands.The damage found is not due to a production fault.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: TIPCAM 1 S 3D LAP, 0°
• Type of Device: TIPCAM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 18669643
• MDR Text Key: 334913899
• Report Number: 9610617-2024-00032
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 26605AA
• Device Catalogue Number: 26605AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other