MAUDE Adverse Event Report: COVIDIEN 7462 VISTEC SPG 8X4 12P T-10'S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	7462
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that the pack was supposed to have 10 sponge gauze in it, but it only had 9.The counting method is manual and the miscount was identified during initial count prior to commencement of surgery.No patient involved, no injury.
Additional Manufacturer Narrative
A device history record (dhr) review was completed for the reported lot number.There were no manufacturing related issues related to the issue reported.No samples were provided for evaluation however a corrective and preventive action (capa) was opened to investigate the issue further.The capa is currently in the investigation stages.Any actions that take place will be designed to prevent the reoccurrence of the reported issue of miscounts.A quality alert was issued to address containment notification to the operators in the vistec room.There was a quality stand down with the operators, and heightened quality inspection has also been implemented with an emphasis on miscounts.

• Brand Name: 7462 VISTEC SPG 8X4 12P T-10'S
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road, po b; augusta GA 30906
• MDR Report Key: 10413112
• Report Number: 1018120-2020-00421
• Device Sequence Number: 14357424
• Product Code: GDY
• UDI-Device Identifier: 10884527017065
• UDI-Public: 10884527017065
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020

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
• Operator of Device: No Information
• Device Model Number: 7462
• Device Catalogue Number: 7462
• Device Lot Number: 19H020462
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 11/03/2020
• Patient Sequence Number: 1