MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 ENDO-FLO IRRIGATOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0037970
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the endo-flo irrigator device is being returned for evaluation.However, at this time has not been received.Based on the information provided to date, no conclusion can be made.Additional information has been requested.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 360 units released for distribution in march, 2018.If/when the sample is received and evaluated or additional information is provided, a supplemental mdr will be submitted.Sample not returned.
Event or Problem Description
As reported, on (b)(6) 2020, the endo-flo irrigator leaked saline from the device during priming.As reported, another device was used to complete the procedure.There were no pieces found detached from the device.There was no reported patient involvement.
Event or Problem Description
As reported, on (b)(6) 2020, the endo-flo irrigator leaked saline from the device during priming.As reported, another device was used to complete the procedure.There were no pieces found detached from the device.There was no reported patient involvement.
Additional Manufacturer Narrative
As reported, the endo-flo irrigator device is being returned for evaluation.However, at this time has not been received.Based on the information provided to date, no conclusion can be made.Additional information has been requested.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in march, 2018.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the results of the device evaluation.The subject product was returned for evaluation.Functional evaluation of the sample found no fluid leak identified from the endo-flo tubing or pump housing or at the luer lock connection.The endo-flo was found to irrigate as intended with no fluid leaks identified.Evaluation of the sample could not reproduce the reported event.No manufacturing anomalies were found.Based on the sample evaluation and investigation performed, the reported event was unconfirmed.H3 other text : sample evaluated.

• Brand Name: ENDO-FLO 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
• MDR Report Key: 10822193
• Report Number: 1213643-2020-20040
• Device Sequence Number: 3760295
• Product Code: HET
• UDI-Device Identifier: 00801741065217
• UDI-Public: (01)00801741065217
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K902722
• 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,Followup
• Report Date (Section B): 11/13/2020

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: 02/28/2021
• Device Catalogue Number: 0037970
• Device Lot Number: JUCQF282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 11/20/2020
• 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