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

Catalog Number	0037970
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the endo-flo irrigator leaked fluid, air and the joint seal was noted to be loose during an unknown procedure.The subject product was not returned for evaluation.Based on the information provided and without having the sample to evaluate, no conclusion 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 complaint reported for this manufacturing lot of (b)(4) units released for distribution in july, 2021.
Event or Problem Description
As reported, during an unknown procedure on (b)(6) 2022, the bard/davol endo-flo irrigator leaked irrigation fluid from the bifurcation.Also reported was an air leak at the same position.As reported the joint seal was loose, but there were no detached pieces.As reported, the pressure at which the device was operated is unknown.There was no reported patient injury.

• Brand Name: ENDO-FLO 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
• 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: 14141569
• Report Number: 1213643-2022-00161
• Device Sequence Number: 17700086
• Product Code: HET
• UDI-Device Identifier: 00801741065217
• UDI-Public: (01)00801741065217
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K902722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2022

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: 06/28/2024
• Device Catalogue Number: 0037970
• Device Lot Number: JUFT2217
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown