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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG AESCULAP SURGICAL INSTRUMENTS GENERAL SURGICAL INSTRUMENTS

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AESCULAP AG AESCULAP SURGICAL INSTRUMENTS GENERAL SURGICAL INSTRUMENTS Back to Search Results
Model Number JK489
Device Problems Shipping Damage or Problem (1570); Manufacturing, Packaging or Shipping Problem (2975); Material Deformation (2976); Material Integrity Problem (2978)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 03/26/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). If additional information is received a follow up report will be submitted.
 
Event Description
It was reported the lids were warped causing sterility concerns. The reporter indicated that upon preparation of the or for an enduro hinge total knee revision (tkr) case, it was discovered that 4 out of the 10 sterile containers for the enduro instrument sets had lids that were warped (likely from shipping). The containers did not seem to be holding a tight vacuum seal around filter. Due to sterility concerns, the case was cancelled and rescheduled for the follow day (b)(6) 2019. The patient was not yet under anesthesia, however, due to the cancellation of the procedure, the patient required an extra day/night in the hospital. The surgery did occur the following day as planned. No patient information has been provided. Additional information has been requested, however, not yet received.
 
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Brand NameAESCULAP SURGICAL INSTRUMENTS
Type of DeviceGENERAL SURGICAL INSTRUMENTS
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP INC
3773 corporate parkway
center valley PA 18034
Manufacturer Contact
lindsay chromiak
3773 corporate parkway
center valley, PA 18034
3145515988
MDR Report Key8545445
MDR Text Key143036218
Report Number2916714-2019-00013
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053389
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberJK489
Device Catalogue NumberJK489
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date03/28/2019
Event Location No Information
Date Manufacturer Received04/08/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/24/2019 Patient Sequence Number: 1
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