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

Model Number 7148

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; 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 gauze is tearing too easily, surgeons are unable to use.

Manufacturer Narrative

An investigation of the reported condition was performed.The device history record (dhr) for lot indicates zero issues were found.A review of maintenance records (both corrective and preventive) and calibration records were reviewed and there were no issues found.All scheduled maintenance and calibration activities were completed on time.The exact root cause of the reported condition could not be determined without an actual sample to examine.If the material was tearing apart too easily it would most likely be an issue of the raw material construction.There have also been reports of the sponges being unfolded prior to use by the end user.The sponges are intended to be used in their folded state so it if they are unfolded prior to use it would contribute to the material coming apart.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, samples are inspected from the beginning, middle, and end of each lot for bad weave.The lot met all defined acceptance requirements and was released.No complaint trend exists and the issue could not be confirmed, therefore, no corrective action is required at this time.This information will be utilized for trending purposes to determine the need for corrective actions.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: 6640895
• MDR Text Key: 77558048
• Report Number: 1018120-2017-05046
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

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: Health Professional
• Device Model Number: 7148
• Device Catalogue Number: 7148
• Device Lot Number: 16J232562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/19/2017
• Initial Date FDA Received: 06/14/2017
• Supplement Dates Manufacturer Received: 05/19/2017
• Supplement Dates FDA Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1