MAUDE Adverse Event Report: INTUITIVE SURGICAL MARYLAND BIPOLAR FORCEPS DAVINCI ; SYSTEM, SURGICAL, CONTROLLED INSTRUMENT

Model Number 420172

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2018

Event Type  Injury  

Event Description

Robotic maryland bipolar forcep 8 mm malfunction during procedure, caused no harm to the pt.

• Brand Name: MARYLAND BIPOLAR FORCEPS DAVINCI
• Type of Device: SYSTEM, SURGICAL, CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL
• MDR Report Key: 7475183
• MDR Text Key: 107104283
• Report Number: MW5076910
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420172
• Device Lot Number: N10180215-515
• 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: 54 YR