DAVOL INC., SUB. C.R. BARD, INC. -1213643 HYDRO-SURG PLUS LAPAROSCOPIC IRRIGATOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
|
Back to Search Results |
|
Catalog Number 0026870 |
Device Problems
Corroded (1131); Smoking (1585)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/24/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Initial evaluation of the returned sample finds for an internal thermal event on the circuit board.Evaluation of the sample is ongoing at this time.When the sample evaluation and investigation have been completed a supplemental mdr will be submitted to document the results.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
|
|
Event Description
|
As reported, during an unspecified procedure on (b)(6) 2022, the bard/davol hydrosurg lap irrigator started smoking and smelling like fire.As reported, the device was pulled out and another device was used to complete the procedure.There was no reported patient or user injury.
|
|
Manufacturer Narrative
|
Initial evaluation of the returned sample finds for an internal thermal event on the circuit board.Evaluation of the sample is ongoing at this time.When the sample evaluation and investigation have been completed a supplemental mdr will be submitted to document the results.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the sample evaluation results.Evaluation identifies the ingress of saline fluid beyond the motor mount and into the unit.Condition resulted in a thermal event (short circuit) related to saline in contact with the circuit board.Based on our evaluation and the condition of the device, the root cause is identified as manufacturing related.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
|
|
Event Description
|
As reported, during a robotic-assisted total laparoscopic hysterectomy procedure on (b)(6) 2022, the bard/davol hydrosurg lap irrigator started smoking and smelling like fire.As reported, the device was pulled out and another device was used to complete the procedure.There was no reported patient or user injury.
|
|
Search Alerts/Recalls
|
|
|