MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. PRECISE BIPOLAR FORCEPS INSTRUMENT; ENDOSCOPIC INSTRUMENT

Model Number 420110-06

Device Problem Malposition of Device (2616)

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

Event Date 03/19/2014

Event Type  malfunction  

Event Description

It was reported that the precise bipolar forceps instrument cable did not allow different movements after the da vinci anterior rectum resection procedure.No fragments fell into the patient.The planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported.

Manufacturer Narrative

The instrument was returned and evaluated.Per the customer reported complaint, failure analysis found that the conductor wires were intact and undamaged, but the drive cable was frayed.The pitch up cable was frayed at the distal clevis hub.Non-intuitive motion occurred as a result.The frayed strands stuck out at the wrist.The other cables at the wrist were undamaged.No other damage was found.The customer reported complaint does not itself constitute a mdr reportable event; however, the damaged cable, found during failure analysis could likely cause or contribute to an adverse event if the failure mode were to recur.

• Brand Name: PRECISE BIPOLAR FORCEPS INSTRUMENT
• Type of Device: ENDOSCOPIC INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA 9408 6
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA 94086
• MDR Report Key: 3788703
• MDR Text Key: 4442595
• Report Number: 2955842-2014-02745
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420110-06
• Device Lot Number: M10130711 473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 90