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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 HYDRO-SURG PLUS LAPAROSCOPIC IRRIGATOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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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.
 
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Brand Name
HYDRO-SURG PLUS LAPAROSCOPIC IRRIGATOR
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
DAVOL SURGICAL INNOVATIONS -9616067
ave. roberto fierro #6408
parque industrial aeropuerto
cd. juarez, chih s.a. de c.v. 32690
MX   32690
Manufacturer Contact
andrew topoulos
100 crossings blvd.
warwick, RI 02886
8005566756
MDR Report Key15026996
MDR Text Key296240304
Report Number1213643-2022-00515
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier00801741000362
UDI-Public(01)00801741000362
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K961492
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0026870
Device Lot NumberJUGQ8006
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2022
Date Manufacturer Received07/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/03/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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