PURSE STRING CLAMP
Received Mar 14, 2017
Report 9610612-2017-00083 · MDR key 6403573
Device
Generic name
General Surgical Instruments
Manufacturer
Aesculap AgModel number
EA323RCatalog number
EA323R
Product problems
- Device Operates Differently Than Expected
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
CORRECTION MADE TO: PRODUCT CODE. PRODUCT CODE FFN.
Additional Manufacturer Narrative
AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem
COUNTRY OF COMPLAINT: FINLAND. 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: 9610612-2017-00093.