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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG TC WIRE HOLDING FORCEPS LAT-JAW 170MM; GENERAL SURGICAL INSTRUMENTS
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AESCULAP AG TC WIRE HOLDING FORCEPS LAT-JAW 170MM; GENERAL SURGICAL INSTRUMENTS Back to Search Results
Model Number LX176R
Device Problem Crack (1135)
Patient Problem No Patient Involvement (2645)
Event Date 04/03/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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 the tc wire holding forceps.The customer stated that two products were received and rejected.The cracks were identified at the facility upon receipt and the forceps were not used; a picture revealed fractures on the inserts.There was no patient involvement or procedure.
 
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Brand Name
TC WIRE HOLDING FORCEPS LAT-JAW 170MM
Type of Device
GENERAL 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 Key8541699
MDR Text Key142930600
Report Number9610612-2019-00293
Device Sequence Number1
Product Code HYA
Combination Product (y/n)N
Reporter Country CodeUK
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 04/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLX176R
Device Catalogue NumberLX176R
Device Lot Number4510089589
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2019
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date04/17/2019
Date Manufacturer Received04/05/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/22/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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