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

Model Number 420205-07

Device Problem Mechanical Jam (2983)

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

Event Date 11/02/2015

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the instrument involved with this complaint and completed investigation.Failure analysis investigation confirmed the customer reported complaint and found the instrument had a bent grip which reduced grip performance.Additionally, failure analysis also found the instrument to have a broken pitch cable at the distal clevis hub.The cable segment that contained the crimp was still installed in the clevis.No other damage or wear marks were observed on the clevis.A device history record (dhr) review for this device was conducted 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.Although the customer reported complaint does not itself constitute a reportable event, this is being reported due to the broken pitch cable found during failure analysis investigation.

Event Description

It was reported that during a da vinci surgical procedure, the jaws locked on the fenestrated bipolar forceps instrument and could not be used.The planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported.There were no reports of any fragment(s) falling into the patient.

• Brand Name: FENESTRATED BIPOLAR FORCEPS
• Type of Device: ENDOSCOPIC ELECTROSURGICAL 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: 5335974
• MDR Text Key: 35255305
• Report Number: 2955842-2015-01548
• 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: 12/14/2015

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: 420205-07
• Device Lot Number: N10140724 095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/14/2015
• Initial Date FDA Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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: 70 YR