MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 DAVOL ADVANTAGE ELECTROSURGICAL ATTACHMENTS; LAPAROSCOPIC PUMP SYSTEM

Catalog Number	0043950
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned for evaluation.Initial evaluation finds all components are in place with no damage noted.Functional evaluation of the sample resulted in no fluid leaks from the trumpet valve & probe tip or at the stop cock connection point.Evaluation of the sample could not reproduce the reported event.The device was found to irrigate as intended with no fluid leaks identified.No manufacturing anomalies were found.To date, this is the only reported complaint for this manufacturing lot.Based on the sample evaluation and investigation performed, the reported event was unconfirmed.It is unclear why the user may have experienced a water leak.The use of this device requires proper set up.Per the instructions-for-use, ¿follow instructions provided with the endo-flo irrigator or other irrigation system of choice for set-up and use with the probe.¿ sample evaluated.
Event or Problem Description
As reported, during an unspecified procedure on (b)(6) 2021, the bard/davol trumpet valve & probe tip device leaked water at the connection of the probe with the aspirator.There was no reported patient injury.

• Brand Name: DAVOL ADVANTAGE ELECTROSURGICAL ATTACHMENTS
• Common Device Name: LAPAROSCOPIC PUMP SYSTEM
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 12219303
• Report Number: 1213643-2021-20195
• Device Sequence Number: 4137050
• Product Code: HET
• UDI-Device Identifier: 00801741065231
• UDI-Public: (01)00801741065231
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K941334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2021

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: 12/28/2021
• Device Catalogue Number: 0043950
• Device Lot Number: JUEN3311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other