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 Codes	Corroded (1131); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, fluid leakage was noted inside of the hydrosurg plus battery compartment at the end of the case.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.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.
Event or Problem Description
As reported, during an unknown procedure on (b)(6) 2021, a bard/davol hydrosurg irrigation device was used.It was reported that at the end of the case while removing the irrigator from the iv pole/neptune, the irrigator was leaking fluid from the battery pack.There was no performance issue and the device functioned as intended.There was no reported patient or user harm.

• 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: 12434804
• Report Number: 1213643-2021-20308
• Device Sequence Number: 19731368
• 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): 08/24/2021

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: 12/28/2023
• Device Catalogue Number: 0026880
• Device Lot Number: JUEZ2115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2021
• 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