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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)(4). 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: 9610612-2017-00083, 9610612-2017-00093.
 
Manufacturer Narrative
Correction made to: product code. Product code ffn.
 
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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 Key6403577
MDR Text Key69946997
Report Number9610612-2017-00093
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 04/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2017
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 Manufacturer02/20/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date02/15/2017
Event Location No Information
Date Manufacturer Received02/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/14/2017 Patient Sequence Number: 1
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