MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. CLEARIFY PLUNGER SPONGE; GAUZE/SPONGE, INTERNAL

Lot Number D2K0719Y

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2023

Event Type  malfunction  

Event Description

During the insertion of the clarify plunger through the trocar during the procedure, the plunger sponge broke off inside the patient.The sponge was retrieved and removed of the field.The packaging wrapper was obtained by leadership, and they are contacting manufacturer.

• Brand Name: CLEARIFY PLUNGER SPONGE
• Type of Device: GAUZE/SPONGE, INTERNAL
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 950 flanders rd; mystic CT 06355
• MDR Report Key: 16529033
• MDR Text Key: 311146402
• Report Number: 16529033
• Device Sequence Number: 1
• Product Code: EFQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: D2K0719Y
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26280 DA
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Hispanic