MAUDE Adverse Event Report: DAVOL SURGICAL INNOVATIONS -9616067 HYDRO-SURG PLUS LAPAROSCOPIC IRRIGATOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0026870
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during set up of a procedure on (b)(6) 2025, four hydro-surg lap irrigators (device #1, #2, #3 & #4) were leaking irrigation fluid after being primed.There was no patient injury.
Additional Manufacturer Narrative
As reported, the hydro-surg plus irrigator was leaking irrigation fluid.The subject device was discarded by the user facility.Based on the information provided, no definitive conclusion can be made at this time.A lot sample has been returned for evaluation and the preliminary evaluation confirms the fluid leak.The root cause investigation is currently ongoing.When the sample evaluation is completed, a supplemental mdr will be submitted.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.This mdr represents the hydro-surg plus laparoscopic irrigator (device # 2).Additional mdrs were submitted to represent the other three hydro-surg plus laparoscopic irrigators (device #1, device #3 & device # 4).Note: section a through f - 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 or Problem Description
As reported, during set up of a procedure on (b)(6) 2025, four hydro-surg lap irrigators (device #1, #2, #3 & #4) were leaking irrigation fluid after being primed.There was no patient injury.
Additional Manufacturer Narrative
As reported, the hydro-surg plus irrigator was leaking irrigation fluid.The subject device was discarded by the user facility.Based on the information provided, no definitive conclusion can be made at this time.A lot sample has been returned for evaluation and the preliminary evaluation confirms the fluid leak.The root cause investigation is currently ongoing.When the sample evaluation is completed, a supplemental mdr will be submitted.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the sample evaluation results.The units that had leaked in use had been discarded by the user.Evaluation of same lot sample finds fluid leak at the elbow shroud, noting a small amount of uv adhesive at the joint of the co-joined tube.The fluid leak was determined to be due to a lack of adhesive placed at the time of manufacture, resulting in a weak bond at the tubing connection.Based on the same lot sample the most probable cause may be related to weak bonding of manufacturing related issue.This supplemental mdr represents the hydro-surg plus laparoscopic irrigator (device #2).Additional supplemental mdrs were submitted to represent the other three hydro-surg plus laparoscopic irrigators (device #1, device #3 & device #4).Note: section a through f: 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.

• Brand Name: HYDRO-SURG PLUS LAPAROSCOPIC IRRIGATOR
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• 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: 22069843
• Report Number: 1213643-2025-00404
• Device Sequence Number: 13148579
• Product Code: GCJ
• UDI-Device Identifier: 00801741000362
• UDI-Public: (01)00801741000362(17)270728(10)JUJU1655
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K961492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2025

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 Catalogue Number: 0026870
• Device Lot Number: JUJU1655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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