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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 7317 SPG VISTEC 4X4 STR 10'S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

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COVIDIEN 7317 SPG VISTEC 4X4 STR 10'S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE Back to Search Results
Model Number 7317
Device Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/20/2018
Event Type  malfunction  
Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event Description
Customer reports: during a total thyroidectomy case the raytec sponges were fraying.At one point during the case the surgeon was picking out pieces of string from the patient's wound.
 
Manufacturer Narrative
The device history record (dhr) for lot number 18k076562 indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.A lot cannot be released unless it passes all quality and conformance requirements.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.No product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.The reported customer complaint could not be confirmed.A root cause could not be determined.This complaint will be utilized for tracking and trending purposes.
 
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Brand Name
7317 SPG VISTEC 4X4 STR 10'S
Type of Device
GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Manufacturer (Section D)
COVIDIEN
1430 marvin griffin road, po b
augusta GA 30906
MDR Report Key8176010
MDR Text Key130710268
Report Number1018120-2018-00321
Device Sequence Number1
Product Code GDY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 01/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7317
Device Catalogue Number7317
Device Lot Number18K076562
Initial Date Manufacturer Received 11/20/2018
Initial Date FDA Received12/18/2018
Supplement Dates Manufacturer Received11/20/2018
Supplement Dates FDA Received01/23/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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