MAUDE Adverse Event Report: TRUPHATEK INTERNATIONAL LTD. RUSCH TRULED ADULT LARYNGOSCOPE HANDLE SET; LARYNGOSCOPE, RIGID

Catalog Number 0055501

Device Problem Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been returned to the manufacturer at the time of this report.The investigation into this complaint is still in progress.

Event Description

Customer complaint alleges the "truled will not hold a charge.".Alleged issue reported as detected prior to use on patient (pre-testing).No report of patient harm.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).The sample was received from the customer.Based on the lot number it was manufactured in december 2015, and it was determined that the device was out of warranty.

Event Description

Customer complaint alleges the "truled will not hold a charge.".Alleged issue reported as detected prior to use on patient (pre-testing).No report of patient harm.Patient condition reported as "fine".

• Brand Name: RUSCH TRULED ADULT LARYNGOSCOPE HANDLE SET
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TRUPHATEK INTERNATIONAL LTD.; netanya
• Manufacturer (Section G): TRUPHATEK INTERNATIONAL LTD.; 14 benny gaon street; p.o. 8051; netanya 42504 43; IS 4250443
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6609009
• MDR Text Key: 76554093
• Report Number: 8030121-2017-00081
• 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,Followup
• Report Date: 05/23/2017

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 Catalogue Number: 0055501
• Device Lot Number: 1551V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2017
• Initial Date FDA Received: 06/02/2017
• Supplement Dates Manufacturer Received: 07/20/2017
• Supplement Dates FDA Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1