MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC CONNECTING CABLEREUSABLE; ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE

Model Number 8403X

Device Problems Break (1069); Optical Problem (3001)

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

Event Date 07/11/2023

Event Type  Injury  

Manufacturer Narrative

The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that there was an issue with the product 8403zx - c-mac monitor for cmos endoscopes.Loose contact during intubation.It was reported that "during a laryngoscopy, the screen goes black and the light also goes out, so that direct laryngoscopy is also not possible.After wiggling both contacts (cable-handle and cable-screen), light and image go again after a few seconds.Intubation is significantly delayed and no statement about possible aspiration/regurgitation is possible for a short time." there was no patient harm reported.

Manufacturer Narrative

This reported contains corrections from the initial report that was submitted in the following fields: d1, d2, d4, d9, g4, and h6.The following devices were received on the manufacturing site for investigation on (b)(6) 2023: 8403zx - c-mac monitor for cmos endoscopes.8403x - c-mac connecting cable.8403axc - c-mac video laryngoscope mac #3.The following device was received on the manufacturing site for investigation on (b)(6) 2023: 8403bxc - c-mac video laryngoscope mac #4.The investigation has been completed on (b)(6) 2023.Findings: visual and microscopical examination of the devices revealed signs of usage like bruises, wear and slight damages.The c-mac layngoscopes are without functional errors.The only thing that can be seen on the outer surfaces and at the blades are strong traces of bruising.The c-mac monitor is without any functional errors either but the charging socket is worn out and has to be replaced.This is not connected to the described failure pattern.The functional check of the connecting cable shows that the cable is defect / broken due to heavy mechanical stress.Therefore, the cable is most likely the causal product for the reported problem.Section 2.3 has been adjusted accordingly.Based on the available information and the results of the examination, the defect described by the customer can be confirmed.There is no indication for a material-, manufacturing- or design-related failure.The root cause of the reported issue can be traced back to an overload situation.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: C-MAC CONNECTING CABLEREUSABLE
• Type of Device: ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE
• 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: 17470390
• MDR Text Key: 320506997
• Report Number: 9610617-2023-00203
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 04048551389225
• UDI-Public: 4048551389225
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• 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: 11/17/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8403X
• Device Catalogue Number: 8403X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2014
• 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