MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. TENACULUM; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Catalog Number 470207

Device Problems Bent (1059); Difficult to Remove (1528)

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

Event Date 05/05/2017

Event Type  malfunction  

Event Description

The davinci xi tenaculum became bent while in patient's abdomen during robotic hysterectomy, bilateral salpingectomy procedure.It was unable to be removed through trocar by scrub technician.Davinci emergency key used to remove instrument from robotic attachment and was pulled out of abdomen with trocar under verbal order/supervision of surgeon.The case was completed without further incident.Patient transferred to the recovery area in stable condition.

• Brand Name: TENACULUM
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 6618419
• MDR Text Key: 76865402
• Report Number: 6618419
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Catalogue Number: 470207
• Device Lot Number: 1016083-0-0022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.; UNKNOWN.
• Patient Age: 42 YR