MAUDE Adverse Event Report: MEDICAL DEVICES SUNMED; LARYNGOSCOPE

Model Number 5-5852-02

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2019

Event Type  malfunction  

Manufacturer Narrative

The returned product was confirmed to not illuminate when attached to a properly functioning handle.The blades however were determined to be damaged by the customer after the autoclave process performed.The damage to the light cartridges was due to over threading the light cartridge into the blade.

Event Description

The customer alleges that " resus bag is missing the mask." no other details were provided and no patient injury/harm reported.

• Brand Name: SUNMED
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): MEDICAL DEVICES; wazirabad road, ugoki.; sialkot punjab,
• MDR Report Key: 9480972
• MDR Text Key: 191467240
• Report Number: 1314417-2019-00062
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5-5852-02
• Device Lot Number: TB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Type of Device Usage: N
• Patient Sequence Number: 1