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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, hydro-surg irrigator male adapter cracked, unable to attach probe tip securely.Evaluation of the sample finds that the probe tip base broke on the qd adapter.The clear portion is fractured diagonally indicating the distal tip was leveraged in one direction forcibly and the clear portion snaped.Based on the sample condition probe tip base broke due to excessive forces applied while in use.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 one of the hydro-surg plus laparoscopic irrigator used in the case.An additional mdr was submitted to represent another hydro-surg plus laparoscopic irrigator used.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 cholecystectomy, the hydro-surg irrigator broke and malfunctioned during a case.It was reported that the two devices, the plastic at the end where the suction tip was cracked (male adapter), making it impossible to get the proper seal and suction.The surgeon tried turning up the suction for the two that cracked but the suction tip would not stay attached.It was also reported that the surgeon used another new device.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, hydro-surg irrigator male adapter cracked, unable to attach probe tip securely.Evaluation of the sample finds that the probe tip base broke on the qd adapter.The clear portion is fractured diagonally indicating the distal tip was leveraged in one direction forcibly and the clear portion snaped.Based on the sample condition probe tip base broke due to excessive forces applied while in use.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.Addendum: h11: this supplemental mdr is submitted to correct device manufacture date and imdrf annex b code.There is no change to the initial determination.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This supplemental mdr represents one of the hydro-surg plus laparoscopic irrigator used in the case.An additional mdr was submitted to represent another hydro-surg plus laparoscopic irrigator used.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 cholecystectomy, the hydro-surg irrigator broke and malfunctioned during a case.It was reported that the two devices, the plastic at the end where the suction tip was cracked (male adapter), making it impossible to get the proper seal and suction.The surgeon tried turning up the suction for the two that cracked but the suction tip would not stay attached.It was also reported that the surgeon used another new device.There was no reported 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: 19882753
• Report Number: 1213643-2024-00385
• Device Sequence Number: 4134099
• Product Code: GCJ
• UDI-Device Identifier: 00801741000362
• UDI-Public: (01)00801741000362
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2024
• 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