MAUDE Adverse Event Report: COVIDIEN 6522 LAP SPG 18X18 STR P-W SOF; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	6522
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The customer reported that when using lumicell during a lumpectomy, the doctor noted many particles of lint that would not be visible to the naked eye and could only be attributed to the lap sponges.

• Brand Name: 6522 LAP SPG 18X18 STR P-W SOF
• 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: 10953558
• Report Number: 1018120-2020-00427
• Device Sequence Number: 583491
• Product Code: GDY
• UDI-Device Identifier: 10884527020485
• UDI-Public: 10884527020485
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2020

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?: Yes
• Operator of Device: No Information
• Device Model Number: 6522
• Device Catalogue Number: 6522
• Device Lot Number: 20F032862
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 12/05/2020
• Patient Sequence Number: 1
• Patient Age: 66 YR