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

Catalog Number 0026870

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/17/2022

Event Type  malfunction  

Manufacturer Narrative

The sample was not available for return.As reported, spewing of black flecks was noted from the trumpet of hydrosurg irrigator when it was being tested with the saline.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 1440 units released for distribution in august, 2022.

Event Description

As reported, during preparation for a laparoscopic cholecystectomy procedure, a bard/davol hydrosurg irrigation device was spewing black flecks from the trumpet when it was being tested with the saline prior to the start of the procedure.It was reported that or staff took all related pieces off the field and opened a new device.The device was not used on the patient and there was no user harm.

• Brand Name: HYDROSURG 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: 15729825
• MDR Text Key: 303341943
• Report Number: 1213643-2022-00707
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• 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: JUGV8303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2022
• 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