MAUDE Adverse Event Report: STRYKER; STRYKER LAP SPONGES IN BREAST ABDOMINOPLASTY TRAY

Catalog Number	DYNJ0428947F
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that in the middle of bilateral breast tissue expander exchange to implants and fat grafting procedure, prior to the closing of the surgical site, irrigation was required to successfully remove lint coming from the lap sponges.Per report, the lint from the lap sponges was also found on drapes and staff's gloves.Reportedly, the lap sponges were not inspected for lint prior to use.General anesthesia was used; however, there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.No impact to the patient, the procedure, or the total length of the procedure was reported.There was no serious injury or follow up care reported related to the event.Due to the reported incident and in an abundance of caution, this medwatch is being filed.The sample was not available to be returned for evaluation.A third party notification has been completed with the manufacturer of the lap sponges involved with this event.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that prior to the closing of the surgical site, irrigation was required to successfully remove lint coming from the lap sponges.

• Common Device Name: STRYKER LAP SPONGES IN BREAST ABDOMINOPLASTY TRAY
• Manufacturer (Section D): STRYKER; 2825 airview boulevard; kalamazoo MI 49002
• MDR Report Key: 7784939
• Report Number: 1423395-2018-00047
• Device Sequence Number: 1195556
• Product Code: FTN
• UDI-Device Identifier: 10889942541584
• UDI-Public: 10889942541584
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/15/2018

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 Catalogue Number: DYNJ0428947F
• Device Lot Number: 18FKE327
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 08/15/2018
• 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
• Patient Age: 51 YR
• Patient Weight: 69