Model Number 471205-17 |
Device Problem
Thermal Decomposition of Device (1071)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/11/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that during central processing, the fenestrated bipolar forceps instrument had a burn mark under tip.No known impact or patient consequence was reported.Intuitive surgical inc.(isi) followed up with the initial reporter and obtained the following additional information: the fenestrated bipolar forceps instrument had burn spots identified during central processing.
|
|
Manufacturer Narrative
|
Intuitive surgical, inc.(isi) has not received the fenestrated bipolar forceps instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.
|
|
Manufacturer Narrative
|
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The fenestrated bipolar forceps was analyzed and found to have charring and localized melting at the grip base between the grips.The instrument passed the electrical continuity test.
|
|
Event Description
|
Refer to h10/h11 for follow-up information.
|
|
Search Alerts/Recalls
|