MAUDE Adverse Event Report: COVIDIEN 7148 VISTEC SPG 4X4 16P T-10S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 7148

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reports the sponges fraying and leaving strings in the incision.

Manufacturer Narrative

A review of the device history record (dhr) for lot no.18a068662 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.For sterilized products, the device history record and the sterilization documents undergo further review prior to release.Inspectors routinely examine a statistical sample both physically and visually.Two (2) photo samples were provided for analysis.From the photograph, it is clear to see some threads from raw edges that are folded in the sponge.It was also noted that the sponge is unfolded.These sponges are designed to be used in the folded state.The purpose of the sponge is to maintain the 4¿x4¿ form to eliminate the sponge from linting, fraying, shredding and losing its absorbency.Without an actual sample, further testing for a definitive root cause for fraying could not be conducted.Additional information such as how the sponge was utilized in the surgery would have also aided in the investigation.The reported customer complaint could not be confirmed.A root cause could not be determined.This complaint will be used for trending and tracking purposes.

• Brand Name: 7148 VISTEC SPG 4X4 16P T-10S
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 8121245
• MDR Text Key: 128936006
• Report Number: 1282497-2018-08188
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 7148
• Device Catalogue Number: 7148
• Device Lot Number: 18A068662
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 11/30/2018
• Supplement Dates Manufacturer Received: 11/05/2018
• Supplement Dates FDA Received: 02/06/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other