MAUDE Adverse Event Report: COVIDIEN; LARYNGOSCOPE, ENDOSCOPE

Catalog Number 173049

Device Problem Material Separation (1562)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Three (3) complaints were received during this report period.Of these, 2 were not returned for evaluation ((b)(4).One (1) was determined to be misapplication ((b)(4)).All 3 reported devices are labeled for single use.None of the devices were reprocessed and reused.No remedial action was taken.

Event Description

This report summarizes 3 malfunction events which are associated with undesired damage or breakage of materials used in device construction.These reports were received from various sources.Patient information was confirmed for 1 event.(b)(6).

• Type of Device: LARYNGOSCOPE, ENDOSCOPE
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5611089
• MDR Text Key: 44474903
• Report Number: 9612501-2016-00072
• Device Sequence Number: 1
• Product Code: GCI
• Combination Product (y/n): N
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 173049
• Type of Device Usage: N
• Patient Sequence Number: 1