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

Model Number	7318
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that during a head <(>&<)> neck procedure, the device was not intact, leaving sponge particles in the patient's surgical wound.The customer further reports that there was no patient injury.
Additional Manufacturer Narrative
The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all dhrs are reviewed and approved by quality, prior to release of product.Because a sample was not returned, we were unable to perform a thorough follow up investigation to include functional and visual evaluations to confirm the reported issue.However, when linting is present, it is typically a failure of the tentering process which occurs prior to the conversion and packaging process.During the slitting of the gauze into slit widths, the blades can create short fibers that the vacuum system picks up.If the vacuum is not set strong enough, then not all of the loose fibers are picked up.It should also be noted that the gauze sponge product is meant to be used without unfolding.If the sponge is unfolded prior to use, fibers entrapped within the folds can float away from the product and fall onto surfaces such as an open incision, cut or wound.As part of continuous improvements, a corrective and preventive action was implemented for linting in the ¿vistec x-ray detectable sponges¿ family on (b)(6) 2017, which includes the lot for which this complaint was issued.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.If samples are received, the investigation will be reopened and responded to accordingly.This complaint will be used for qa tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Submission date: 09/06/2018.An investigation was performed for the reported customer complaint: ¿the customer reported that during a head & neck procedure, the device was not intact, leaving sponge particles in the patient's surgical wound.The customer further reports that there was no patient injury.¿ a review of the device history record (dhr) for lot no.17a059262 indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.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.Two (2) samples were received for evaluation.Upon removal of the sponges from both packaging trays, containing ten (10) sponges each, a visual inspection was performed.There was no visible lint in the trays nor was there lint falling from the sponges.Potential causes of linting can include: the blades require replacement or sharpening, the sharping stones require replacement or they are not adjusted correctly, or the recommended sharpening of the knives after every roll change was not adhered to.In addition, scalloped blades, vendor changes or material variances could contribute or cause linting.Based on the available information, there is insufficient evidence indicating specifically that any of these scenarios occurred.The reported customer complaint is not confirmed.A root cause could not be determined.However, a formal capa investigation is currently in progress to investigate this issue.This complaint will be utilized for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VISTEC
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 1647 perkins rd; augusta GA 30913
• MDR Report Key: 6862507
• Report Number: 1018120-2017-05095
• Device Sequence Number: 566637
• Product Code: GDY
• UDI-Device Identifier: 00884521537395
• UDI-Public: 00884521537395
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2018

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
• Operator of Device: Health Professional
• Device Model Number: 7318
• Device Catalogue Number: 7318
• Device Lot Number: 17A059262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 08/14/2017; 04/04/2018
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 03/13/2018; 09/06/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other