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.#8030121-2017-00123).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 for evaluation.A visual exam was performed and it was observed that the acrylic foot (base) and light pipe are broken.No other defects were observed.Based on the visual exam the complaint was confirmed.A capa was opened to address this issue.A conclusion code could not be chosen as the complaint was confirmed; however, a root cause could not be 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.#8030121-2017-00123).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: 6841472
• MDR Text Key: 84993397
• Report Number: 8030121-2017-00122
• 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

• Date FDA Received: 09/05/2017
• 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
• Date Manufacturer Received: 09/11/2017
• 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