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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL VISISTAT 35W NON-STERILE

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TELEFLEX MEDICAL VISISTAT 35W NON-STERILE Back to Search Results
Catalog Number 528236
Device Problems Difficult to Open or Close (2921); Mechanical Jam (2983)
Patient Problem No Patient Involvement (2645)
Event Date 10/01/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The facility has communicated that the device is not available for evaluation. P/n 528236 is not being manufactured currently, however, another part number from the same family was use for the verification of failure mode reported in the current manufacturing process and was conducted as follows: 13 staplers were taken from the current production from p/n 528235 visistat 35w non-sterile lot# 73j1800742 the staplers were functionally inspected and the issue reported "stapler jamming" was not observed in the current manufacturing process, the staples were loaded and released correctly. The device history review for the product visistat 35r 6/box lot 73a1800774 investigation did not show issues related to the complaint. The device has not been returned for investigation. Corrective actions cannot be established, the customer complaint cannot be confirmed, and the root cause cannot be determined since it is necessary to receive the physical sample to perform a proper investigation and to confirm the alleged defect. If the alleged defective samples become available at a later date, this complaint will be updated accordingly. Teleflex will continue to monitor and trend related events.

 
Event Description

It was reported that the stapler is not working; sometimes it gets stuck and other times it does not close properly.

 
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Brand NameVISISTAT 35W NON-STERILE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
rancho el descanso
tecate 21478
MX 21478
Manufacturer Contact
effie jefferson
3015 carrington mill blvd
morrisville 27560
9194332672
MDR Report Key7996651
MDR Text Key124965091
Report Number3003898360-2018-00857
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeEZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/09/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/23/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number528236
Device LOT Number73A1800774
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/31/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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