MAUDE Adverse Event Report: INTUITIVE DAVINCI/SI INSTRUMENT/PK

Model Number PK DISSECTING FORCEPS

Device Problems Difficult to Remove (1528); Mechanical Jam (2983)

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

Event Date 02/24/2016

Event Type  malfunction  

Event Description

During davinci laparoscopic hysterectomy surgeon needed to adjust rumi uterine manipulator.Rn suggested to remove instruments while attention was down at vagina.Surgical tech removed instrument from arm 1 without incident.Upon attempt to remove instrument from arm 2 surgical tech was unable to remove, causing a recoverable fault.Emergency wrench was tried and unable to remove instrument from arm.Rn called technical support, instructed surgical team to hit emergency stop, use 1 hand to grasp release button on side of instrument and with other hand to firmly pull up until instrument came out.Surgical tech followed instructions from technical support and was unable to remove instrument from arm.Surgeon completed surgery after checking that no pt harm had come of instrument being removed.

• Brand Name: DAVINCI/SI INSTRUMENT/PK
• Type of Device: DAVINCI/SI INSTRUMENT/PK
• Manufacturer (Section D): INTUITIVE; sunnyvale CA 94086
• MDR Report Key: 5466503
• MDR Text Key: 39336384
• Report Number: MW5060577
• 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: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PK DISSECTING FORCEPS
• Device Catalogue Number: 420227
• Device Lot Number: N10150831613
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 64