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

Catalog Number DYNJ0428947F

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/02/2018

Event Type  malfunction  

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 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.

• Type of Device: STRYKER LAP SPONGES IN BREAST ABDOMINOPLASTY TRAY
• Manufacturer (Section D): STRYKER; 2825 airview boulevard; kalamazoo MI 49002
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093 ; 2249311514
• MDR Report Key: 7784939
• MDR Text Key: 117430775
• Report Number: 1423395-2018-00047
• Device Sequence Number: 1
• Product Code: FTN
• UDI-Device Identifier: 10889942541584
• UDI-Public: 10889942541584
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ0428947F
• Device Lot Number: 18FKE327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 69