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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG PURSE STRING CLAMP GENERAL SURGICAL INSTRUMENTS

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AESCULAP AG PURSE STRING CLAMP GENERAL SURGICAL INSTRUMENTS Back to Search Results
Model Number EA323R
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going.
 
Event Description
Country of complaint: (b)(6). It was reported that the forceps (purse string clamp was used for surgery. The suture did not hold, the forceps did not function properly. New operation was necessary due to lesion. All med watch submissions related to this report are: 9610612-2017-00177, 9610612-2017-00185. Incident was reported by the same initial reporter by mdrs: 9610612-2017-00083 and 9610612-2017-00093. Its unknown if these were used on the same patient with information reported.
 
Manufacturer Narrative
Investigation: the investigation was carried out by ats. The movement of the clamp with the labeling (b)(4) is a little bit too smooth. The correct function is still given, the instrument is working. Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers. The device history file has been checked and found to be according to our specification valid at the time of production. No similar incidents have been filed with products from this batch. Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably user related. Rational: according to the investigation of ats, the instruments are working. Thus is can exclude a material or manufacturing caused error. Corrective action: according to sop (b)(4) a capa is not necessary.
 
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Brand NamePURSE STRING CLAMP
Type of DeviceGENERAL SURGICAL 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
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key6455137
MDR Text Key71582995
Report Number9610612-2017-00177
Device Sequence Number1
Product Code FFN
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEA323R
Device Catalogue NumberEA323R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date03/20/2017
Device Age8 MO
Event Location No Information
Date Manufacturer Received03/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2016
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: 04/03/2017 Patient Sequence Number: 1
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