MAUDE Adverse Event Report: MEDSORB DOMINICANA, S.A. NEURO SPONGE; GAUZE/SPONGE, INTERNAL

Model Number	30-056
Medical Device Problem Codes	Material Separation (1562); Material Integrity Problem (2978); Protective Measures Problem (3015)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: the sponge is supplied to deroyal by medsorb dominicana.A supplier corrective action request (scar) was issued to medsorb.In its response medsorb provided the following root causes for the reported issues: neuro sponge not detected by x-ray: x-ray material comes with coa showing compliance to astm f640-12.The product is manufactured according to requirements.The instructions for use (ifu) packaged with the product establishes the following: "the size and position of the radiopaque markers may impact their visibility; small patties may be obscured from the x-ray when behind bone or in morbidly obese individuals." string removed: this did not occur during the manufacturing process as there was no detection of thread attachment failures in process.Additionally, there have been no material changes.The product is designed so that the string is available for location of the sponge.The string is not meant to be used to remove or relocate the sponge in situ.This is stated in the ifu.The root cause for this type of failure is usually associated with improper use of the device by using the string to relocate or remove the sponge.Corrective action: no corrective actions have taken at this time.Investigation summary an internal complaint (call (b)(4).) was received indicating that a neuro sponge (part 30-056, lot 19082732) miscount occurred during a procedure.The missing sponge was undetected during an x-ray.The physician reopened the patient's incision and removed the sponge.A sample was unavailable for return.During follow-up communication with the initial reporter, it was confirmed that the device's x-ray element was intact but the string was removed.The part is complete upon arrival to deroyal from the supplier, medsorb.A scar was issued to medsorb, and a response was received and accepted february 19 by deroyal personnel.The neuro sponges have an x-ray detectable strip on the pattie itself.The product is received at deroyal with a certificate regarding the x-ray detectability of the product.The statement on the certificate says, "products contain radiopaque x-ray detectable material that is tested in accordance with astm f640-12." there have been 3,934 units sold from february 2019 to present with a complaint-to-sales ratio of 0.000763.There have been three complaints during this time frame, but no other like complaints reported for the same part number.The investigation is complete at this time.If new or critical information is received, this report will be updated.
Event or Problem Description
A neuro sponge miscount occurred.The sponge was not detected during an x-ray.The doctor went into the operative site, found the sponge, and removed it.

• Brand Name: NEURO SPONGE
• Common Device Name: GAUZE/SPONGE, INTERNAL
• Manufacturer (Section D): MEDSORB DOMINICANA, S.A.; zona franca industrial; san pedro de macoris; san pedro de macoris ; DR
• MDR Report Key: 11423705
• Report Number: 1060680-2021-00001
• Device Sequence Number: 11721308
• Product Code: EFQ
• UDI-Device Identifier: 00749756254243
• UDI-Public: 00749756254243
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K791871
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2021

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: Health Professional
• Device Model Number: 30-056
• Device Lot Number: 19082732
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1