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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. HYDRO-SURG PLUS LAPAROSCOPIC IRRIGATOR LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 0026870
Device Problem Fluid Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/08/2019
Event Type  Malfunction  
Manufacturer Narrative

The subject product was discarded by the user facility and was not returned for evaluation. Based on the available information and without a sample to evaluate, we are unable to determine what may have caused the reported leakage into the battery compartment. 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 Description

It was reported that the hydro-surg irrigation leaked. It was noted that under the pump of the nezhat there was a small hole where the water was leaking. No patient injury was reported. Based on details provided the fluid may have leaked into the battery compartment.

 
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Brand NameHYDRO-SURG PLUS LAPAROSCOPIC IRRIGATOR
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
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
steven figueroa
100 crossings blvd.
warwick, RI 02886
4018258460
MDR Report Key9530839
MDR Text Key193052488
Report Number1213643-2019-12534
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK961492
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 12/30/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/30/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0026870
Device LOT NumberJUCXF442
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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