MAUDE Adverse Event Report: COVIDIEN CURITY LAP SPG 18X4 P-W STR TRY 5'S; LAP SPONGES

Model Number	6045
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 01/27/2017.An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
It was reported to covidien on (b)(6) 2017 that an issue occurred with lap sponges.The customer states the package contained 6 sponges instead of 5.Issue was noticed prior to use.
Additional Manufacturer Narrative
A sample was received for evaluation and the complaint has been confirmed.A device history record (dhr) review was completed for lot# 14l057562x and there were no manufacturing related issues related to the complaint issued for this lot.All scheduled maintenance and calibration activities were completed on time.A review of maintenance records (both corrective and preventive) and calibration records were reviewed and there were no issues.All scheduled maintenance and calibration activities were completed on time.There was no related process or material changes related to the reported condition for this product.The root cause for this complaint has been identified as an operator error that occurred during product allocation.The trend analysis doesn¿t support opening a formal corrective/preventative action (capa).A quality alert has been issued to the employee and the site will continue to monitor this to avoid a future reoccurrence of the reported issue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CURITY LAP SPG 18X4 P-W STR TRY 5'S
• Common Device Name: LAP SPONGES
• Manufacturer (Section D): COVIDIEN; 1430 mrvin griffin road; augusta,ga GA 30913
• MDR Report Key: 6285080
• Report Number: 1018120-2017-00007
• Device Sequence Number: 16546987
• Product Code: GDY
• UDI-Device Identifier: 10884527020478
• UDI-Public: 0110884527020478
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 11/17/2017

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: Other
• Device Model Number: 6045
• Device Catalogue Number: 6045
• Device Lot Number: 14LD57562X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/06/2017
• Supplement Date Received by Manufacturer: 01/06/2017
• Initial Report FDA Received Date: 01/27/2017
• Supplement Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1