MAUDE Adverse Event Report: MITG - RF SURGICAL SYSTEMS SITUATE; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	L1818-04P01C-1
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during right breast wire localized lumpectomy with right sentinel node biopsy and lumicell probe, where patient's clear imaging was taken of the breast for cancer screening, the linting of the sponge then appeared in the breast pocket upon visualization of the imaging scans.Surgeon created a pocket in the breast to insert an imaging probe but prior to insertion of probe, the physician inserted a laparotomy sponge to absorb addition fluids in the pocket.X-ray was required to assist in location all the lint and most were removed.Photograph was received and showed several long strings left in the patient's cavity.
Additional Manufacturer Narrative
Additional information: a1, d9, g1(mfr contact first name, last name, email, phone number), g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.Two devices were available for evaluation.Visual inspection noted the unit had an excessive fabric detached from gauze.The gauze was removed from the package.One of the gauze is very bloody.Linting was noticed and the gauze was unfolded.An unused package of gauze was also returned and no linting was noted.Functional testing found that the gauze showed linting and the gauze had been manipulated.The unused gauze had not been manipulated.It was reported that gauze had strings detached.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: the gauze sponges are made with natural cotton and may produce lint or fibers when unfolded or manipulated.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SITUATE
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): MITG - RF SURGICAL SYSTEMS; 2101 faraday; carlsbad CA 92008
• MDR Report Key: 11454384
• Report Number: 3005883396-2021-00006
• Device Sequence Number: 11542601
• Product Code: GDY
• UDI-Device Identifier: 20884521700953
• UDI-Public: 20884521700953
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: Health Professional
• Device Expiration Date: 06/20/2025
• Device Model Number: L1818-04P01C-1
• Device Catalogue Number: L1818-04P01C-1
• Device Lot Number: 200806AT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention