MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. MARYLAND BIPOLAR FORCEPS

Model Number 470172

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2017

Event Type  Injury  

Event Description

Maryland bipolar forceps were in the pt's abdomen when it was noted that the plastic covering over the tip of the instrument was broken, not broken off, just broken.No harm to the pt.

• Brand Name: MARYLAND BIPOLAR FORCEPS
• Type of Device: MARYLAND BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; bldg 101; sunnyvale CA 94086 5304
• MDR Report Key: 7095749
• MDR Text Key: 94266058
• Report Number: MW5073807
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470172
• Device Lot Number: N101704110096
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR