MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TIPCAM1 S 3D LAP, 30; RIGID VIDEO LAPAROSCOPE

Model Number 26605BA

Device Problem No Display/Image (1183)

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

Event Type  malfunction  

Manufacturer Narrative

The affected tipcam1 s 3d lap, 30° rigid video endoscope was evaluated by the manufacturer.The described failure (image loss) could be confirmed.The investigation showed that when the video endoscope is connected to a camera control unit (ccu) it is not recognized by the ccu.In the corresponding ifu of the product the following safety-relevant warnings are stated: "warning: in the event of image failure immediately remove tipcam1 s 3d from the patient." "warning: the video system can malfunction during use.An adequate replacement system must be kept available." there was no injury or any adverse impact to the patient, user or third reported in connection to this event.

Event Description

As per a manufacturer incident report we received from the factory in (b)(6): camera had an image failure in the middle of the op.Error could not be corrected even by restarting the processor and reconnecting the tipcam.Mfr's.Internal complaint # (b)(4).

• Brand Name: TIPCAM1 S 3D LAP, 30
• Type of Device: RIGID VIDEO LAPAROSCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 12576583
• MDR Text Key: 274740637
• Report Number: 9610617-2021-00066
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04048551347843
• UDI-Public: 4048551347843
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2021

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
• Device Operator: Health Professional
• Device Model Number: 26605BA
• Device Catalogue Number: 26605BA
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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