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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG 1/2-SIZE LID W/RETENTION PLATE GOLD STERILE TECHNOLOGY

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AESCULAP AG 1/2-SIZE LID W/RETENTION PLATE GOLD STERILE TECHNOLOGY Back to Search Results
Model Number JK388
Device Problem Device Fell (4014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2021
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 jk388-1/2-size lid w/retention plate gold. According to the complaint description, it was reported that the device fell. This event/malfunction prolonged the surgery for 15 minutes. Additional information was not provided nor available / was not available. The adverse event / malfunction is filed under aag reference (b)(4).
 
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Brand Name1/2-SIZE LID W/RETENTION PLATE GOLD
Type of DeviceSTERILE TECHNOLOGY
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 Key12787841
MDR Text Key280599751
Report Number9610612-2021-00720
Device Sequence Number1
Product Code FLE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K792558
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberJK388
Device Catalogue NumberJK388
Was Device Available for Evaluation? No
Date Manufacturer Received01/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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