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

Model Number 7318

Device Problems Material Separation (1562); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 08/28/2017.An investigation is currently underway.Upon completion, the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states that during testing, the sponges were found torn, damaged and unusable.The customer further reports there was no patient involved.

Manufacturer Narrative

An investigation of the reported condition was performed.There were no samples received with this complaint.Therefore, an examination of the reported condition could not be made.A review of device history record (dhr) was performed for the manufacturing lot.There were no manufacturing related issues related to the complaint issued for this lot.The reported condition is not confirmed.Without a sample, the probable root cause 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 tracking and 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: 6824754
• MDR Text Key: 83798929
• Report Number: 1018120-2017-05084
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

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: 7318
• Device Catalogue Number: 7318
• Device Lot Number: 17F241462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/02/2017
• Initial Date FDA Received: 08/28/2017
• Supplement Dates Manufacturer Received: 08/02/2017
• Supplement Dates FDA Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1