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

Model Number 420227-03

Device Problem Malposition of Device (2616)

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

Event Date 06/24/2014

Event Type  malfunction  

Event Description

It was reported that in central processing, the pk dissecting forceps instrument was observed to be broken.The tips did not meet.There was no report of fragments falling into a patient.There was no patient harm, adverse outcome or injury reported.

Manufacturer Narrative

The instrument was returned and evaluated.Failure analysis found the instrument's grip tips to be bent.One grip was bent which caused side to side misalignment of the grip.There was a.074 offset at the tips.The bent grip did not exhibit separation of the yaw pulley and pulley cover at the glue joint, however likely cause of bending remains overloading at the tip.Failure analysis concluded that the bent damage may be due to mishandling/misuse.Failure analysis investigation also found the following damages: the instrument's pitch cable was frayed.The conductor wires were intact and undamaged, however the drive cable was frayed.The pitch down cable was frayed at the distal clevis hub.Frayed strands were observed to be sticking out at the wrist of the instrument.The other cables at the wrist of the instrument were undamaged.In addition, the instrument's main tube had scratch marks/abrasions.The distal end of the main tube had various scratch marks with light material removal.The scratches were.021 -.159 in length and was not aligned with the tube axis.No other damage was found.The instruments and accessories user manual specifically states: general precautions and warnings handle instruments with care.Avoid mechanical shock or stress that can cause damage to the instruments.The customer reported complaint does not in itself constitute a mdr reportable event; however; the frayed cable and various scratch marks on the main tube with light material removal found during failure analysis if to recur could cause or contribute to an adverse event.

• 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: 3943481
• MDR Text Key: 22001525
• Report Number: 2955842-2014-04376
• 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: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420227-03
• Device Lot Number: M10131030 999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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