MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 HYDROSURG 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	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, there was fluid in the battery compartment of the bard/davol hydrosurg plus irrigator that was noted during the procedure.The sample was discarded and not available for return.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.Should additional information be provided, a supplemental mdr will be submitted.
Event or Problem Description
As reported, on (b)(6) 2021 during an unknown procedure a bard/davol hydrosurg irrigation device was leaking fluid from the battery compartment.It was reported that the device did function as intended.There was no reported harm to patient or user.

• Brand Name: HYDROSURG 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: 12433213
• Report Number: 1213643-2021-20312
• Device Sequence Number: 14266627
• Product Code: GCJ
• UDI-Device Identifier: 00801741010224
• UDI-Public: (01)00801741010224
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K961492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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: 04/28/2024
• Device Catalogue Number: 0026880
• Device Lot Number: JUFR2870
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/07/2021
• 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