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

Catalog Number 0026870

Device Problems Corroded (1131); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2023

Event Type  malfunction  

Manufacturer Narrative

As reported, hydrosurg irrigator leaked fluid from battery.Based on evaluation of the device, a fluid leak presented and passed the lip seal barrier.Rtv is identified on the motor mount along with cracks in the motor mount allowing fluid to pass through the mount and down the sides of the motor to the pc board and battery compartment.The reported event is confirmed and the root cause determined to be manufacturing related.This mdr represents the bard/davol hydrosurg laparoscopic irrigator (device #1).An additional mdr was submitted to represent the three bard/davol hydrosurg laparoscopic irrigator (device #2).

Event Description

As reported, during a procedure, the or staff noticed the hydrosurg irrigation device leaking fluid from the battery pack.It was reported that the same device was used to complete the procedure.No patient harm or injury was reported.

• 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 Key: 16612879
• MDR Text Key: 312031428
• Report Number: 1213643-2023-00117
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00801741000362
• UDI-Public: (01)00801741000362
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0026870
• Device Lot Number: JUGV8255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2023
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other