MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 HYDRO-SURG PLUS LAPAROSCOPIC IRRIGATOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0026870
Medical Device Problem Codes	Corroded (1131); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the bard/davol hydrosurg irrigator leaked fluid from the battery compartment.It is reported that the subject device is being returned for evaluation; however, at this time has not been received.Based on the condition reported, the root cause is most probably due to fluid ingress into the unit housing.However, without sample evaluation, a definitive conclusion cannot be made.If/when the sample is received and evaluated, a supplemental mdr will be submitted.
Event or Problem Description
As reported, during a procedure on (b)(6) 2021, the bard/davol hydrosurg plus w/ smokevac trumpet valve & tip leaked fluid from the battery compartment.As reported, the length of device use is unknown the procedure was completed using the same device.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, the bard/davol hydrosurg irrigator leaked fluid from the battery compartment.It is reported that the subject device is being returned for evaluation; however, at this time has not been received.Based on the condition reported, the root cause is most probably due to fluid ingress into the unit housing.However, without sample evaluation, a definitive conclusion cannot be made.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the results of the device evaluation.The subject product was returned for evaluation.Visual examination identified corrosion of the internal components, which was due to fluid ingress into the motor housing.Based on evaluation of the device it appears that the fluid leak presented and passed the lip seal barrier.Cracks and excessive rtv were identified on the motor mount allowing fluid to pass through the motor mount and down the sides of the motor to the pc board and battery compartment.Based on the sample evaluation and investigation performed, the root cause for the issues experience by the user are determined to be 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.H3 other text : sample evaluated.
Event or Problem Description
As reported, during a procedure on (b)(6) 2021, the bard/davol hydrosurg plus w/ smokevac trumpet valve & tip leaked fluid from the battery compartment.As reported, the length of device use is unknown the procedure was completed using the same device.There was no reported patient injury.

• Brand Name: HYDRO-SURG PLUS LAPAROSCOPIC IRRIGATOR
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 12638129
• Report Number: 1213643-2021-20360
• Device Sequence Number: 3292256
• Product Code: GCJ
• UDI-Device Identifier: 00801741010224
• UDI-Public: (01)00801741010224
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K961492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2024
• Device Catalogue Number: 0026870
• Device Lot Number: JUFP0423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other