MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. ENDOWRIST STAPLER 45; ENDOSCOPIC INSTRUMENT

Model Number 470298-11

Device Problems Nonstandard Device (1420); Device Displays Incorrect Message (2591); Difficult to Open or Close (2921); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2016

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the instrument involved with this complaint and completed investigation.Failure analysis removed the instrument's housing to find the roll bearing to be broken.A device history record (dhr) review for this device and did not find any non-conformances that would affect any material of the final product and/or the quality or performance of the instrument.The customer reported event does not itself constitute an mdr reportable event; however, the broken roll bearing found during failure analysis could cause or contribute to an adverse event if the failure mode were to recur.

Event Description

It was reported that during a da vinci assisted gastrectomy procedure, the stapler 45 instrument locked up and would not work or release and another instrument was used to complete the procedure.Intuitive surgical, inc.(isi) followed up with the reporter to obtain additional information about the complaint.The customer performed approximately 4 fires successfully with the stapler 45 instrument before the reported issue occurred.The customer was guided to press the emergency stop and got a please use release kit message.The customer attempted to use the instrument release kit (irk) but was not able to open the jaws of the instrument.The surgeon confirmed he did not have to cut tissue to free the stapler 45 instrument.The stomach tissue that was removed was part of planned procedure.The procedure was converted to traditional laparoscopic surgery and completed successfully with a traditional laparoscopic stapler.The patient has been discharged and there is no report of post-operative complications.

• Brand Name: ENDOWRIST STAPLER 45
• Type of Device: ENDOSCOPIC INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA
• MDR Report Key: 5847280
• MDR Text Key: 52398148
• Report Number: 2955842-2016-00545
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K140553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/14/2016

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: 470298-11
• Device Lot Number: S10160401 0017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/14/2016
• Initial Date FDA Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2955842-071416-010-R
• Patient Sequence Number: 1