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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG SENSATION MICRSCIS S/S BAY STR 120/245MM SCISSOR

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AESCULAP AG SENSATION MICRSCIS S/S BAY STR 120/245MM SCISSOR Back to Search Results
Model Number FM124R
Device Problems Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Country of complaint: (b)(6). Staff member in hospital injured by protruding instrument from outer box. Instrument had breached inner box packaging and pierced outer shipping box.
 
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Brand NameSENSATION MICRSCIS S/S BAY STR 120/245MM
Type of DeviceSCISSOR
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 Key5685186
MDR Text Key46779906
Report Number2916714-2016-00438
Device Sequence Number1
Product Code HRR
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
EXEMPT
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,Followup
Report Date 12/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFM124R
Device Catalogue NumberFM124R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date01/16/2016
Event Location No Information
Date Manufacturer Received01/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/10/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/27/2016 Patient Sequence Number: 1
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