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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ACCULAN 3TI RECIPROCATING SAW POWER SYSTEMS

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AESCULAP AG ACCULAN 3TI RECIPROCATING SAW POWER SYSTEMS Back to Search Results
Model Number GA674
Device Problem Mechanical Problem (1384)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 07/02/2019
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 acculan 3ti. It was reported that on (b)(6) 2019, a patient with left atrial space occupying disease, underwent atrial lesion resection. When the operation was ready, the battery power system was checked and it was found that the device was not working. The operation was delayed, could not be carried out smoothly, and increased the risk of operation. The patient recovered well after surgery and did not cause any harmful injury. There was an significant surgery delay. Additional information was not provided nor available / was not available. Additional information has been requested but not yet received as of this report. Additional patient information is not available. The adverse event / malfunction is filed under aag reference (b)(4).
 
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Brand NameACCULAN 3TI RECIPROCATING SAW
Type of DevicePOWER SYSTEMS
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
christian von der grün
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key10385611
MDR Text Key202359522
Report Number9610612-2020-00360
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeCH
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 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGA674
Device Catalogue NumberGA674
Device Lot Number52315683
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/10/2020 Patient Sequence Number: 1
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