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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #23 BASIC INSTRUMENTS

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AESCULAP AG CARBON STEEL SCALPEL BLADES #23 BASIC INSTRUMENTS Back to Search Results
Model Number BB523
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: one box was received with 98 pieces within the dispenser; they were in a decontaminated condition. Failure description - of the 98, 70 packages were damaged and 28 were undamaged. Investigation: visual inspection showed damaged dispenser packaging, and some of the blades protruded through the individual packs. Batch history review: the device quality and manufacturing history records have been checked for the lot numbers and found to be according to the specifications valid at the time of production. No similar incidents have been filed with products from this batch. Conclusion and root cause: the root cause of the problem is most likely related to an improper transport of the product. Rationale: according to the quality standard and history records, a material defect and production error can be excluded. Investigations lead to the assumption that the visibly damaged dispenser packages were caused due to an improper transport of the product. There is also the possibility that the cause could be traced back to an increased load, e. G. Drops, impacts, or similar, during transport. A capa was initiated and completed.
 
Event Description
It was reported that there was an issue with the surgical blades within the dispenser. This occurred preoperatively and there was no patient harm. The box/dispenser with individual packs was noted to have damaged packaging inside of it and some of the blade tips protruded. The box was removed and not used. Additional information was not provided.
 
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Brand NameCARBON STEEL SCALPEL BLADES #23
Type of DeviceBASIC INSTRUMENTS
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
lindsay chromiak
3773 corporate parkway
center valley, PA 18034
MDR Report Key8693076
MDR Text Key147860057
Report Number9610612-2019-00361
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 06/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBB523
Device Catalogue NumberBB523
Device Lot Number4509140958
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/16/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date05/27/2019
Event Location No Information
Date Manufacturer Received05/15/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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