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 Thermal Decomposition of Device (1071); Corroded (1131); Fluid/Blood Leak (1250); Smoking (1585)

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

Event Date 10/07/2022

Event Type  malfunction  

Manufacturer Narrative

As reported, the bard/davol hydrosurg laparoscopic irrigation system started to smoke at the end of procedure.The subject device has been returned.Evaluation identifies the ingress of saline fluid beyond the motor mount and into the unit.Condition resulted in a thermal event (short circuit) related to saline in contact with the circuit board.Based on our evaluation and the condition of the device, the root cause is identified as manufacturing related.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

As reported per mi case# (b)(4): on (b)(6) 2022 a bard/davol hydrosurg irrigator device started to smoke at the end of the procedure.It was reported that the device was immediately removed from the room and removed the battery.As reported, they were able to complete the procedure and no patient harm 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: 15721911
• MDR Text Key: 303024579
• Report Number: 1213643-2022-00704
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0026870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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