MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. 8 MM PROGRASP FORCEPS; ENDOSCOPIC INSTRUMENT

Model Number 470093-09

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 08/08/2017

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument associated with this complaint and has completed its evaluation.The instrument was found to have a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was missing from clevis 0.032 x 0.046 in the clevis.The clevis did not exhibit any damage or wear marks.Isi has conducted a device history record (dhr) review for this device and did not find any non-conformances that were related to the reported event.The customer reported complaint does not itself constitute an mdr reportable event; however, the broken pitch cable found during failure analysis could cause or contribute to an adverse event if the malfunction were to recur.

Event Description

It was reported that during a da vinci-assisted prostatectomy procedure, the customer noted a broken off wire on the prograsp forceps instrument.There was no report of fragment(s) falling inside the patient, patient harm, adverse outcome or injury.

• Brand Name: 8 MM PROGRASP FORCEPS
• 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 ; 4085232420
• MDR Report Key: 6865734
• MDR Text Key: 86161388
• Report Number: 2955842-2017-00599
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• 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: 08/24/2017

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: 470093-09
• Device Lot Number: N10160607 0066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/24/2017
• Initial Date FDA Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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: 60