MAUDE Adverse Event Report: COVIDIEN VISTEC; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 7462

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 10/23/2017.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reports that the x-ray strip fell out of the x-ray detectable sponge.

Manufacturer Narrative

There were no samples received with this complaint therefore an examination of the reported condition could not be made.A review of the device history record (dhr) was not performed during this investigation as the lot number was not received with the complaint.All device history records are reviewed and approved by quality prior to release of product.Because there was no lot number, a date of manufacture could not be determined.Since this complaint will be considered unconfirmed, no corrective or preventive actions will be taken at this time.If additional information or samples are received, the investigation will resume as needed.This complaint will be used for trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VISTEC
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 1647 perkins rd; augusta GA 30913
• Manufacturer (Section G): COVIDIEN; 1647 perkins rd; augusta GA 30913
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6969630
• MDR Text Key: 90689470
• Report Number: 1018120-2017-05105
• Device Sequence Number: 1
• Product Code: GDY
• 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: 02/19/2018

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: Other
• Device Model Number: 7462
• Device Catalogue Number: 7462
• Device Lot Number: UNIKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/13/2017
• Initial Date FDA Received: 10/23/2017
• Supplement Dates Manufacturer Received: 06/13/2017
• Supplement Dates FDA Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1