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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG DISP.UNIV-SEALING UNIT F/10/12MM TROCARS LAPAROSCOPIC SURGERY

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AESCULAP AG DISP.UNIV-SEALING UNIT F/10/12MM TROCARS LAPAROSCOPIC SURGERY Back to Search Results
Model Number EK002SU
Device Problem Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2020
Event Type  Malfunction  
Manufacturer Narrative

Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.

 
Event Description

It was reported that there was an issue with product disp. Univ-sealing. It was reported that the valve inside the seal was damaged and dropped into the body. The damaged valve was recovered and the patient was not affected. There was no patient harm. Additional information was not provided nor available / was not available. Additional patient information is not available. The adverse event / malfunction is filed under aag reference (b)(4).

 
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Brand NameDISP.UNIV-SEALING UNIT F/10/12MM TROCARS
Type of DeviceLAPAROSCOPIC SURGERY
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
christian von der grün
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key10283228
MDR Text Key204977203
Report Number9610612-2020-00260
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/16/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberEK002SU
Device Catalogue NumberEK002SU
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/13/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2020
Was Device Evaluated By Manufacturer? No
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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