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 Problem 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 case.Evaluation of the sample confirmed a fluid leak from the outer shroud most likely originating at the inner and outer sleeve joint inside of the elbow shroud.Based on our evaluation and the condition of the device the root cause determined to be manufacturing related.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in june 2022.This mdr represents the hydro-surg irrigator (device #2).An additional mdr was submitted to represent the hydro-surg irrigator (device #1).

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: 16612883
• MDR Text Key: 312031633
• Report Number: 1213643-2023-00118
• 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: JUGS0725
• 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: 06/09/2022
• 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