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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG BOTTOM FOR 1/1 CONTAINER HEIGHT:135MM STERILE TECHNOLOGY

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AESCULAP AG BOTTOM FOR 1/1 CONTAINER HEIGHT:135MM STERILE TECHNOLOGY Back to Search Results
Model Number JK442
Device Problems Device Reprocessing Problem (1091); Moisture or Humidity Problem (2986)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/29/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Manufacturing site evaluation: evaluation on-going.

 
Event Description

Country of complaint: usa. The customer reported moisture in the primeline lid in surgery. The surgery was delayed 15-20 minutes. There was no harm to the patient. Two med watch reports filed for this incident include: 2916714-2016-00845, 2916714-2016-00844.

 
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Brand NameBOTTOM FOR 1/1 CONTAINER HEIGHT:135MM
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
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key6001246
MDR Text Key56541049
Report Number2916714-2016-00844
Device Sequence Number1
Product Code FLE
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK792558
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 12/05/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/05/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberJK442
Device Catalogue NumberJK442
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date09/09/2016
Event Location No Information
Date Manufacturer Received09/06/2016
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: 10/05/2016 Patient Sequence Number: 1
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