MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. MARYLAND BIPOLAR

Model Number 470172

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2018

Event Type  malfunction  

Event Description

Surgeon using maryland bipolar when a piece of plastic broke off inside the patient.Surgeon able to retrieve piece of plastic.Surgeon performed visual sweep prior to closing and noted no other debris.No harm to patient.Manufacturer: please note that we do not send products to the manufacturer, but you may arrange for pick-up by sending an e-mail to the address below.

• Brand Name: MARYLAND BIPOLAR
• Type of Device: MARYLAND BIPOLAR
• Manufacturer (Section D): INTUITIVE SURGICAL, INC. ; 1266 kifer rd.; building 101; sunnyvale CA 94086 5304
• MDR Report Key: 7435733
• MDR Text Key: 105803206
• Report Number: MW5076507
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470172
• Device Lot Number: N101710060198
• Was Device Available for Evaluation?: No
• 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 Age: 47 YR