MAUDE Adverse Event Report: TELEFLEX MEDICAL DISPOGRIP SU CONV LARYNGOSCOPE HANDLE

Catalog Number 88800

Device Problem Corroded (1131)

Patient Problem No Patient Involvement (2645)

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Received one (1) 8880 dispogrip su conv laryngoscope handle for investigation.Upon receipt a visual inspection was performed to determine if the light handle had been subjected to any abuse/misuse/damage.At first glance the heavy corrosion residue is visible.Very heavy deposits of corrosion are visible on the connection end of the handle.Heavy, white powdery corrosion has completely encroached the electrical contact pin area.Lighter deposits of corrosion have migrated down the handle toward the bottom cap.A functional inspection could not be performed due to the corroded electrical contact points.Based on the physical evidence discovered during the investigation, the very heavy corrosion is the result of leaking batteries.It is not known why the batteries leaked.The manufacturing date code dates the release of the handle batch, october 2016.This puts approximately 2.5 years on this handle in storage, or on a crash cart.This handle is disposable.The complaint has been confirmed, however the actual cause for battery leakage, which may be age, cannot be definitively assigned.

Event Description

The complaint is reported as: "pulled this out to find it had corroded.Even in the battery area it is corroded." no patient involvement.

• Brand Name: DISPOGRIP SU CONV LARYNGOSCOPE HANDLE
• Type of Device: DISPOGRIP
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 8611723
• MDR Text Key: 145106010
• Report Number: 3011137372-2019-00136
• 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
• Type of Report: Initial
• Report Date: 04/22/2019

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: No Information
• Device Expiration Date: 10/25/2019
• Device Catalogue Number: 88800
• Device Lot Number: 16102501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Initial Date Manufacturer Received: 04/22/2019
• Initial Date FDA Received: 05/15/2019
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: NOT REPORTED.