MAUDE Adverse Event Report: SUZHOU MECCAN IMP.& EXP CO., GREENLINE; LARYNGOSCOPE

Model Number 5-5338-12

Device Problem Defective Component (2292)

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

Event Date 04/09/2020

Event Type  malfunction  

Manufacturer Narrative

A supplemental mdr will be submitted once the investigation is complete.

Event Description

The customer allege "the light does not work even if the product is completely new." no other details were provided and no patient injury/harm reported.

Manufacturer Narrative

Product described in incident was unable to be tested for functionality due to unit not being returned to sunmed.To perform investigation, a quantity of two 5-5338-12 (greenline led disposable laryngoscope handle) lot numbers 20200103 & 20191201 were pulled for testing.Lot number 20190304 was not tested due to no product in stock.Upon further testing, both handles powered on with initial engagement of a greenline d pro miller blade.Both handles were cycled 100 times each with no corresponding functional issues.

Event Description

The customer allege the " the light does not work even if the product is completely new." no other details were provided and no patient injury/harm reported.

• Brand Name: GREENLINE
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): SUZHOU MECCAN IMP.& EXP CO.,; 12 east chunshen lake road; xiangcheng district; china
• MDR Report Key: 10074500
• MDR Text Key: 191676464
• Report Number: 1314417-2020-00019
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5-5338-12
• Device Lot Number: 20190304
• Patient Sequence Number: 1