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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE RENEWAL; ETHICON ENDOPATH® XCEL¿ BLUNT TIP TROCAR, W/SMOOTH SLEEVE & ADJUSTABLE PLUG

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MEDLINE RENEWAL; ETHICON ENDOPATH® XCEL¿ BLUNT TIP TROCAR, W/SMOOTH SLEEVE & ADJUSTABLE PLUG Back to Search Results
Model Number K012644
Device Problem Break (1069)
Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Event Date 06/04/2018
Event Type  malfunction  
Manufacturer Narrative
It was reported that the reprocessed ethicon h12lp trocar broke inside a patient during a procedure.Per report, the physician was able to locate the broken piece and successfully retrieve it from the patient.The reporting facility stated that they were able to grab another device and the surgery commenced without incident.There was no report of serious injury, adverse patient consequence or prolonged anesthesia related to the incident.The sample was not returned for evaluation.A root cause of the failure could not be determined at this time.Due to the reported incident and in an abundance of caution, renewal is filing this medwatch report.If additional relevant information becomes available, a supplemental medwatch will be filed.
 
Event Description
It was reported that the reprocessed ethicon h12lp trocar broke inside a patient.
 
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Type of Device
ETHICON ENDOPATH® XCEL¿ BLUNT TIP TROCAR, W/SMOOTH SLEEVE & ADJUSTABLE PLUG
Manufacturer (Section D)
MEDLINE RENEWAL
1500 ne hemlock ave
redmond OR 97756
Manufacturer Contact
stephen wilson
1500 ne hemlock ave
redmond, OR 97756
MDR Report Key7646389
MDR Text Key112846966
Report Number3032391-2018-00006
Device Sequence Number1
Product Code NLM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/28/2018
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? Yes
Device Operator Physician
Device Expiration Date04/30/2021
Device Model NumberK012644
Device Catalogue NumberH12LP
Device Lot Number378574
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/08/2018
Initial Date FDA Received06/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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