MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LIGHT SOURCE 500XL XENON; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE

Model Number 72200568

Device Problems Overheating of Device (1437); Protective Measures Problem (3015); Unexpected Shutdown (4019)

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

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that a patient was hospitalized due to lateral collateral ligament injury.During the examination of the injury, the light source 500xl xenon suddenly alerted with an e13 error, and the light went out.The procedure was successfully completed with a non-significant delay using a back-up device.No patient complications were reported.

Manufacturer Narrative

The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.The e13 error code is a feature that alerts the user of a temperature issue and makes the devices shut down to prevent it from increasing the temperature.As a result, the device is working as intended and the issue will not contribute to serious injury.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: LIGHT SOURCE 500XL XENON
• Type of Device: IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12871104
• MDR Text Key: 281277411
• Report Number: 1643264-2021-02424
• Device Sequence Number: 1
• Product Code: FFS
• UDI-Device Identifier: 03596010643070
• UDI-Public: 03596010643070
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K994084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200568
• Device Catalogue Number: 72200568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female