MAUDE Adverse Event Report: TRUPHATEK INTERNATIONAL LTD. RUSCH GREEN RUSCHLITE DISP MTL MAC 3.5; LARYNGOSCOPE, RIGID

Catalog Number 004551035

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 08/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has been received by the manufacturer, however the investigation of said device in still in pr ogress at the time of this report.A follow up report will be submitted at the conclusion of the device investigation.

Event Description

Customer complaint alleges "customer opened two devices and found the fiber optic bundles broken from the blades".(second device event captured in mfr.Rpt.# 8030121-2017-00122).It is unclear if the device was in the clinical setting.There was no report of patient involvement.There was no report of patient harm.

Manufacturer Narrative

(b)(4).The sample was returned to the manufacturer (truphatek) for evaluation.Truphatek reports that a visual exam was performed and it was observed that the light guide was broken.They have stated that a combination of breakable material named pmma used in the light guide, and an external force (coming as a result of handling /re-packing/unknown external force) could have caused the light guides to break.The actual root cause cannot be established, however it can be assumed that the items have been exposed to high levels of external force.A capa was opened to address this issue.A conclusion code could not be found as the complaint was confirmed; however, a root cause was not established.

Event Description

Customer complaint alleges "customer opened two devices and found the fiber optic bundles broken from the blades".(second device event captured in mfr.Rpt.#8030121-2017-00122).It is unclear if the device was in the clinical setting.There was no report of patient involvement.There was no report of patient harm.

• Brand Name: RUSCH GREEN RUSCHLITE DISP MTL MAC 3.5
• 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: 6841561
• MDR Text Key: 86137903
• Report Number: 8030121-2017-00123
• 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: 08/16/2017

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: 004551035
• Device Lot Number: 1703351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 09/05/2017
• Supplement Dates Manufacturer Received: 09/26/2017
• Supplement Dates FDA Received: 09/29/2017
• 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