MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HIGH FREQUENCY CABLE; HM CABLE

Model Number 277

Device Problem Flare or Flash (2942)

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

Event Type  malfunction  

Event Description

Manufacturer incident report #(b)(4) received from the factory in (b)(6): the event occurred in the united kingdom.The following problem description was submitted to karl storz: cable was reported to have "burst" into flames.The cable was unplugged, thrown to the floor, and extinguished.No injury to the patient, user, or third was reported.A complaint review for this article and similar articles was performed for the timeframe (b)(6) 2020 - (b)(6) 2022.Adverse events that could be considered similar to the current one and caused or contributed to serious injury could be found.Thus, it is concluded that contribution to a serious injury of this malfunction is likely and a report to the fda is required.

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.

Manufacturer Narrative

The malfunction (burned cable) can be confirmed.The cable is separated into two parts and visibly carbonized at the separation point.This kind of defect indicates that the voltage peak was too high for the cable.This normally happens if the cable is strongly kinked.Consequently, the cable got damaged internal and therefore there is a higher resistance and thus a higher temperature development.Based on the cables age, a combination of user error and expected wear and tear is to be considered as a root cause.

Event Description

Internal karl storz reference number:(b)(4).

• Brand Name: HIGH FREQUENCY CABLE
• Type of Device: HM CABLE
• 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 90245-5017 ; 4242188738
• MDR Report Key: 15392875
• MDR Text Key: 305986079
• Report Number: 9610617-2022-00264
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K945380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

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 Operator: Health Professional
• Device Model Number: 277
• Device Lot Number: EG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/09/2022
• Supplement Dates Manufacturer Received: 10/27/2022
• Supplement Dates FDA Received: 10/28/2022
• 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