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

Model Number 7317

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2021

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 stated there were 11 sponges in the pack instead of 10.There was no patient harm.

Manufacturer Narrative

The device history record for the reported lot number was reviewed and indicated that the product was released accomplishing all quality standards.One unsealed sample with lot number 20a095562 was received for evaluation.After reviewing the returned sample, the reported issue was confirmed; there were 11 sponges returned.Brainstorming activities took place with the area supervisor, quality engineer, area mechanic, and manufacturing associate to determine the root cause of the reported issue.Scale challenge checks for all vistec machines were performed.All bands on all vistec machines were inspected and tightened.Compressor plates on all vistec machines were replaced.Control plan for heightened inspection was implemented and being performed.Based on the available information, the exact root cause could not be determined.As part of continuous improvements, a corrective action has been opened to investigate the issue further.An alert was issued to the operators in the vistec room to make them aware of the reported complaint.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: 11578666
• MDR Text Key: 243418177
• Report Number: 1018120-2021-00438
• Device Sequence Number: 1
• Product Code: GDY
• UDI-Device Identifier: 10884527016990
• UDI-Public: 10884527016990
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7317
• Device Catalogue Number: 7317
• Device Lot Number: 20A095562
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/22/2021
• Patient Sequence Number: 1