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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA JARIT COHEN ACORN CANNULA; INTERUTERINE PROBE

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INTEGRA JARIT COHEN ACORN CANNULA; INTERUTERINE PROBE Back to Search Results
Model Number 505-230
Device Problem Detachment Of Device Component (1104)
Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 08/07/2017
Event Type  Injury  
Event Description
Patient admitted for laparoscopy/d and c, patient discharged the same day.Patient presented to facility the following day reporting a foreign body fell out of her vaginal canal upon bearing down for a bowel movement.Foreign body believed to be tip of cannula used in procedure on previous day.Tip connects to surgical equipment with luer lock and disconnected inside the vaginal canal.
 
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Brand Name
COHEN ACORN CANNULA
Type of Device
INTERUTERINE PROBE
Manufacturer (Section D)
INTEGRA JARIT
york PA 17402
MDR Report Key6800805
MDR Text Key83030494
Report NumberMW5071632
Device Sequence Number1
Product Code LKF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number505-230
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/14/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age32 YR
Patient Weight98
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