MAUDE Adverse Event Report: COVIDIEN 6522 LAP SPG 18X18 STR P-WX200; LAP SPONGE

Model Number 6522

Device Problem Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/11/2014

Event Type  Injury  

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a lap sponge.The customer states that a procedure was performed in a male patient.When the assistant counted the medical supplies that were used in the procedure, he/she realized that a sponge was missed.A x-ray exam was performed in order to detect if it was inside the thorax or abdominal cavity of the patient but it was not detected.The physician decided to remove it from the patient.It was possible to see the detectable band of the removed sponge by x-ray exam but it was not detected when it was inside the patient.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

The actual complaint sample was not returned for review by the customer; however, three photos of the reported condition were submitted with the complaint.The three x-ray photos were evaluated for the reported condition.One x-ray photo appeared to show an x-ray detectable handle.The other photos potentially showed the sponge inside the body.As part of the manufacturing process, a device history record (dhr) is generated for lot 140000620262x which confirms that the lot met all acceptable criteria prior to release.Because a physical sample was not returned for evaluation of the detectable part of the sponge; the blue x-ray strip which is 3.5 inches by 5/16 inch could not be performed on the x-ray detectable handle.The potential root cause may have been a variation within the equipment which may have reduced the readability of the element.There is not a complaint trend that exists and a root cause for the reported condition cannot be specifically identified.Product code 6522 lot 140000620262x was manufactured with a lap sponge that is provided by a (b)(4) for medical products.The lot #14004a was received at covidien for incoming raw material inspection.The lot 14004a was subsequently released to production per the certificate of analysis from the (b)(4).As a precaution a vendor quality alert will be issued to the vendor notifying them of the reported condition.This issue will be reviewed during the monthly report out for the factory.No changes to the quality control sampling plans are deemed necessary.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.No formal corrective action preventive action has been created for this complaint.This complaint will be used for trending purposes and reviewed with plant management.

• Brand Name: 6522 LAP SPG 18X18 STR P-WX200
• Type of Device: LAP SPONGE
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road; augusta GA 30906
• Manufacturer (Section G): COVIDIEN; 1430 marvin griffin road; augusta GA 30906
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4760139
• MDR Text Key: 5794588
• Report Number: 1018120-2015-00006
• Device Sequence Number: 1
• Product Code: EFQ
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6522
• Device Catalogue Number: 6522
• Device Lot Number: 140000620262X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other