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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 SILVER LIDS BASIS

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AESCULAP AG 1/2-SIZE LID W/RETENTION PLATE SILVER LIDS BASIS Back to Search Results
Model Number JK389
Device Problems Contamination (1120); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/30/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going.
 
Event Description
Country of complaint: usa. Retention plates are releasing, causing the set to be contaminated. Facility implemented a preventative maintenance of lids/bottom in 2017 to be examined and repaired by aesculap. Project was completed in end of 2017. Issue is occurring with newly repaired lids and newly replaced retention plates. Rep has evaluated 2 lids/plates that customer provided, which had said issue occur last week. Rep could not locate visual issues with items, not could replicate/simulate the issue which occurred/is occurring. Frequency of occurrence - several times per week. No patient injury. A 60 minutes delay in surgery.
 
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Brand Name1/2-SIZE LID W/RETENTION PLATE SILVER
Type of DeviceLIDS BASIS
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
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
MDR Report Key7652663
MDR Text Key112844713
Report Number9610612-2018-00287
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberJK389
Device Catalogue NumberJK389
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date06/21/2018
Event Location No Information
Date Manufacturer Received06/01/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/29/2018 Patient Sequence Number: 1
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