TC WIRE HOLDING FORCEPS LAT-JAW 170MM
Received Apr 23, 2019 · Event occurred Apr 3, 2019
Report 9610612-2019-00293 · MDR key 8541699
Device
Generic name
General Surgical Instruments
Manufacturer
Aesculap AgModel number
LX176RCatalog number
LX176R
Lot number
4510089589
Product problems
- Crack
- Crack
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. 9610612). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
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.