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

Catalog Number	0026880
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the hydrosurg irrigation device was leaking a brown colored fluid from the battery housing during use.The sample is not available for return.Based on the condition reported, the root cause is most probably due to fluid ingress into the unit housing.However, based on the information available and without having the sample to evaluate, as such no conclusion can be made.Note, the date of event is considered to be a best estimate as (b)(6) 2021 based on the date of awareness.Should additional information be provided, a supplemental mdr will be submitted.Sample discarded.
Event or Problem Description
As reported, during an unknown procedure the hydrosurg lap irrigation device was leaking a brown colored fluid from the battery housing during use.It was reported that the fluid leak was noted after spiking and priming the iv bag but the device was used for the entire case.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: 12468878
• Report Number: 1213643-2021-20324
• Device Sequence Number: 14397845
• Product Code: GCJ
• UDI-Device Identifier: 00801741010224
• UDI-Public: (01)00801741010224
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/31/2021

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: 03/28/2024
• Device Catalogue Number: 0026880
• Device Lot Number: JUFQ3335
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/14/2021
• 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