MAUDE Adverse Event Report: INTUITIVE SURGICAL DAVINCI FENESTRATED BIPOLAR FORCEP 8MM

Model Number 420205

Device Problems Device Stops Intermittently (1599); Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2016

Event Type  Injury  

Event Description

A (b)(6) female undergoing total robotic hysterectomy, bso and cystoscopy.Operating room staff reported 8mm fenestrated bipolar davinci forcep was working off and on from the first use.The cord was changed out, all connections were checked, and the instrument was ultimately changed out.The initial forcep was removed from service, charge rn was notified.The surgeon felt that the end was misaligned, no pieces were noted to be missing.The new instrument worked without problems or incident.

• Brand Name: DAVINCI FENESTRATED BIPOLAR FORCEP 8MM
• Type of Device: DAVINCI FENESTRATED BIPOLAR FORCEP 8MM
• Manufacturer (Section D): INTUITIVE SURGICAL
• MDR Report Key: 5784835
• MDR Text Key: 49397333
• Report Number: MW5063325
• Device Sequence Number: 1
• Product Code: NAY
• 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: 07/07/2016

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
• Device Operator: Health Professional
• Device Model Number: 420205
• Device Lot Number: N1160414 111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/07/2016
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR