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 Codes	Corroded (1131); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, hydro-surg irrigator had fluid leak.Based on the information provided, no definitive conclusion can be made at this time.The subject product is not available for evaluation.There are multiple potential causes as to why a fluid leak may present at the bottom of the pump assembly.Without the subject product to evaluate, a root cause or probable root cause cannot be determined.A review of the manufacturing records confirms that the lot was manufactured to specification.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.H3 other text : not returned.
Event or Problem Description
As reported, during a procedure, the hydro-surg leaked irrigation fluid immediately after connecting to the irrigation fluid.It was reported that new device was used to complete the procedure and there was no patient injury.
Event or Problem Description
As reported, during a procedure, the hydro-surg leaked irrigation fluid immediately after connecting to the irrigation fluid.It was reported that new device was used to complete the procedure and there was no patient injury.
Additional Manufacturer Narrative
As reported, hydro-surg irrigator had fluid leak.Based on the information provided, no definitive conclusion can be made at this time.The subject product is not available for evaluation.There are multiple potential causes as to why a fluid leak may present at the bottom of the pump assembly.Without the subject product to evaluate, a root cause or probable root cause cannot be determined.A review of the manufacturing records confirms that the lot was manufactured to specification.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the sample evaluation results.Sample evaluation confirms for the reported complaint condition of a fluid leak.Visual examination of the returned device found minor corrosion inside the hydro-surg battery case.Based on evaluation of the device fluid leaked into the pump housing and presented in the area the battery housing.Fluid leak presented and passed the lip seal barrier through the motor mount as seen by fluid visible on the motor itself.Based on our evaluation and the condition of the device the root cause determined to be manufacturing related.Updated fields: b4, d9, g3, g6, h2, h3, h6, h10.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.H3 other text : sample evaluated.

• 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: 18784153
• Report Number: 1213643-2024-00057
• Device Sequence Number: 12848000
• Product Code: GCJ
• UDI-Device Identifier: 00801741000362
• UDI-Public: (01)00801741000362
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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
• Device Lot Number: JUHX0462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2023
• 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