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

Catalog Number	0026870
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, hydrosurg irrigator cap fell off at the start of procedure.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 (b)(4) units released for distribution in feb, 2024.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 laparoscopic hemicolectomy procedure on (b)(6) 2024, the plastic white cap of hydro-surg irrigator fell onto the floor when hooking up at start of case and became unsterile.It was reported that tubing did not work, and suction could not be maintained, it was unknown whether the white cap was checked and secured prior to use.The procedure was completed using another hydrosurg device of the same lot.There was no patient injury.

• Brand Name: HYDRO-SURG PLUS LAPAROSCOPIC 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: 19646188
• Report Number: 1213643-2024-00345
• Device Sequence Number: 6587243
• Product Code: GCJ
• UDI-Device Identifier: 00801741000362
• UDI-Public: (01)00801741000362
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K961492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2024

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: JUJN2042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2024
• 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