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

Model Number 7317

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2018

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

The customer states the gauze is falling apart.

Manufacturer Narrative

The device history record (dhr) for lot number 18j083562 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.A photograph was provided for evaluation.The reported even was unable to be confirmed from analysis/visual inspection of the photograph.Without the physical sample, testing for the definitive root cause of the shredding could not be conducted.The purpose of the sponge is to maintain the 4¿x4¿ form which will eliminate linting, fraying, shredding and loss of absorbency of the sponge.Knowing how the sponge was utilized in the surgery would have also provided additional insight into the investigation.The reported event of shedding is unconfirmed based on the photograph provided with this complaint.The reported customer complaint could not be confirmed.A root cause could not be determined.This complaint will be used for tracking and trending purposes.

• 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 Key: 8157465
• MDR Text Key: 130163097
• Report Number: 1018120-2018-00316
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7317
• Device Catalogue Number: 7317
• Device Lot Number: 18J083562
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 12/05/2018
• Supplement Dates FDA Received: 01/23/2019
• Patient Sequence Number: 1