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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG MIASPAS TL RONGEUR 6MM 320MM STR; RETRACTORS AND INSTRUMENTS

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AESCULAP AG MIASPAS TL RONGEUR 6MM 320MM STR; RETRACTORS AND INSTRUMENTS Back to Search Results
Model Number FF530R
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2020
Event Type  Injury  
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 a miaspas tl rongeur.During a anterior lumbar interbody fusion (alif) the working end of the rongeur broke during use.The broken fragments were clearly visible and easily removed.All pieces were retrieved using a forceps.An additional medical intervention was necessary.There was no surgical delay.All available information has been provided.The adverse event is filed under reference (b)(4).
 
Event Description
No updates.
 
Manufacturer Narrative
Reference code (b)(4).Device name miaspas tl rongeur 6mm 320mm str.Serial number n/a.Batch number 52380998.Udi device identifier (b)(4).Udi production identifier (b)(4).Basic udi-di n/a unit of use udi-di (b)(4).Manufacturing date (b)(6) 2017.Investigation no product at hand.Pictorial documentation no product at hand.Batch history review the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Explanation and rationale without the product, an exact cause cannot be determined at this moment.Based on the device history records and the complaint review, a material or production related error can be excluded most likely.Therefore at this stage of investigation, we assume that the root cause of the error is most probably usage relate (user notes are listed in the ifu).Corrective action according to sa-de13-m-4-2-04-000-0 (corrective action & preventive action) there is no capa necessary.
 
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Brand Name
MIASPAS TL RONGEUR 6MM 320MM STR
Type of Device
RETRACTORS AND INSTRUMENTS
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM  78501
MDR Report Key10351068
MDR Text Key205291662
Report Number2916714-2020-00297
Device Sequence Number1
Product Code HTX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 10/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFF530R
Device Catalogue NumberFF530R
Device Lot Number52380998
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/30/2020
Event Location Hospital
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/31/2020
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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