MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. PK DISSECTING FORCEPS INSTRUMENT; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number 420227-05

Device Problem Loss of Power (1475)

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

Event Date 01/13/2015

Event Type  malfunction  

Event Description

It was reported that during a da vinci surgical procedure, the pk dissecting forceps instrument couldn't be turned.There was no report of fragments falling 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.Failure analysis investigation found that the pitch cable was broken at the proximal clevis hub.The broken strands stuck out at the wrist.No other damage or wear marks were observed on the clevis.The other cables at the wrist were intact and undamaged.The reported complaint that the instrument couldn't be turned does not itself constitute a reportable event.Recurrence of the alleged failure mode is not expected to likely cause or contribute to a death, serious injury or serious deterioration in the state of health of a patient.However, the broken pitch cable found during failure analysis investigations could cause or contribute to an adverse event if the malfunction were to recur.

• Brand Name: PK DISSECTING FORCEPS INSTRUMENT
• 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 9408 6
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA 94086
• MDR Report Key: 4492426
• MDR Text Key: 5349104
• Report Number: 2955842-2015-00254
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K061260
• 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: 02/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420227-05
• Device Lot Number: N11140530 218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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