MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST ONE VESSEL SEALER; ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES

Lot Number M11180227

Device Problems Break (1069); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2018

Event Type  malfunction  

Event Description

Robot vessel sealer instrument malfunction, blade exposed, while doing robotic assisted hysterectomy.Instrument no longer usable.Checked by intuitive inc., rep.No harm to pt.Fda safety report id# (b)(4).

• Brand Name: ENDOWRIST ONE VESSEL SEALER
• Type of Device: ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES
• Manufacturer (Section D): INTUITIVE SURGICAL, INC. ; sunnyvale CA 94086
• MDR Report Key: 9847936
• MDR Text Key: 184241685
• Report Number: MW5093810
• Device Sequence Number: 1
• Product Code: GEI
• 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: 03/13/2020

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 Expiration Date: 02/29/2020
• Device Lot Number: M11180227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2020
• 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): Other
• Patient Age: 46 YR