MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. IMAGE1 S CONNECT; ENDOSCOPE, NEUROLOGICAL

Model Number TC201US

Device Problems Overheating of Device (1437); Failure to Shut Off (2939); Key or Button Unresponsive/not Working (4063)

Patient Problem Insufficient Information (4580)

Event Date 05/06/2021

Event Type  malfunction  

Event Description

The karl storz endoscopy equipment tc 201 and tc 304 models were having issues where the power would not shut off and the units occasionally overheated.Storz identified a fix to insulate the front cover of the equipment, ultimately reducing water intrusion.It seemed as though the design of the device was not made to handle the cleaning fluid, and when fluid came into the front panel, the power button malfunctioned.Manufacturer response for endoscopy camera control unit, image1 s connect ii (per site reporter).The manufacturer did a full evaluation, and found that additional insulation was necessary to reduce water intrusion on the power buttons and electrical networks.

Event Description

The karl storz endoscopy equipment tc 201 and tc 304 models were having issues where the power would not shut off and the units occasionally overheated.Storz identified a fix to insulate the front cover of the equipment, ultimately reducing water intrusion.It seemed as though the design of the device was not made to handle the cleaning fluid, and when fluid came into the front panel, the power button malfunctioned.Manufacturer response for endoscopy camera control unit, image1 s connect ii (per site reporter): the manufacturer did a full evaluation, and found that additional insulation was necessary to reduce water intrusion on the power buttons and electrical networks.

Event Description

The karl storz endoscopy equipment tc 201 and tc 304 models were having issues where the power would not shut off and the units occasionally overheated.Storz identified a fix to insulate the front cover of the equipment, ultimately reducing water intrusion.It seemed as though the design of the device was not made to handle the cleaning fluid, and when fluid came into the front panel, the power button malfunctioned.Manufacturer response for endoscopy camera control unit, image1 s connect ii (per site reporter): the manufacturer did a full evaluation, and found that additional insulation was necessary to reduce water intrusion on the power buttons and electrical networks.

Event Description

The karl storz endoscopy equipment tc 201 and tc 304 models were having issues where the power would not shut off and the units occasionally overheated.Storz identified a fix to insulate the front cover of the equipment, ultimately reducing water intrusion.It seemed as though the design of the device was not made to handle the cleaning fluid, and when fluid came into the front panel, the power button malfunctioned.Manufacturer response for endoscopy camera control unit, image1 s connect ii (per site reporter): the manufacturer did a full evaluation, and found that additional insulation was necessary to reduce water intrusion on the power buttons and electrical networks.

• Brand Name: IMAGE1 S CONNECT
• Type of Device: ENDOSCOPE, NEUROLOGICAL
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 15013353
• MDR Text Key: 295875821
• Report Number: 15013353
• Device Sequence Number: 1
• Product Code: GWG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/30/2022

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 Model Number: TC201US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2022
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/14/2022; 07/14/2022; 07/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1