MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH DISPOLED DISP FO LARYNGOSCOPE HANDLE

Catalog Number 77700

Device Problems Failure to Conduct (1114); Optical Problem (3001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is unknown if the device was in use or in preparation for patient use at the time the alleged issue was detected.

Event Description

The customer alleges that the light fails to come on or the light would flicker.No patient injury reported.

Manufacturer Narrative

(b)(4).The sample was not returned for evaluation; therefore, the complaint could not be confirmed.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

The customer alleges that the light fails to come on or the light would flicker.No patient injury reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no issues were observed.An emerald rusch fiber-optic blade was attached to the disposed and engaged.After engagement the led beam of light was being projected, but it was lightly flickering.Based on the investigation performed, the reported complaint was confirmed.A possible root cause to this intermittent lighting may be due to debris/residue from manufacturing that caused a faulty connection.The next generation lots have an added cleaning cycle for the connection points in the cartridge, which was put in place to alleviate this issue of intermittent lighting.

Event Description

The customer alleges that the light fails to come on or the light would flicker.No patient injury reported.

• Brand Name: RUSCH DISPOLED DISP FO LARYNGOSCOPE HANDLE
• Type of Device: LARYNGOSCOPE HANDLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 2917 weck drive; research triangle park NC 27709
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5034655
• MDR Text Key: 24252535
• Report Number: 1044475-2015-00346
• 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: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 77700
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2015
• 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