MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. OPTIMA XLED HANDLE MEDIUM FIBRE; LARYNGOSCOPE, RIGID

Catalog Number 3000.500.10

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

It was reported that the light stays on even if the blade comes off.There was patient involvement and no patient harm/adverse event reported.

Manufacturer Narrative

B3: date of event and d5: operator of device are unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

H3.& h6.Component & investigation codes: updated investigation summary: the affected device was received for evaluation.No abnormalities were found on the appearance of the product.After visual inspection, functional testing was performed.As a result of the function test, it was confirmed that the led did not turn off even after removing the blade, confirming the customer's indicated failure.The root cause was the loose switch inside the handle.As a result, the internal switch that was loose was tightened.There was no repair history in the past.This was not a problem related to previous smith repairs.

• Brand Name: OPTIMA XLED HANDLE MEDIUM FIBRE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; bijsterhuizen 22 ¿ 08; wijchen 6604 LD; NL 6604 LD
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18751571
• MDR Text Key: 336416364
• Report Number: 3012542015-2024-00005
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

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: Other
• Device Catalogue Number: 3000.500.10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/24/2024
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 03/03/2024
• Supplement Dates FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1