UNK JARIT RIGHT ANGLE SURGICAL CLAMP
Received Sep 13, 2019 · Event occurred Jul 25, 2019
Report 2523190-2019-00110 · MDR key 9043490
Device
Generic name
Cardiovascular Clamps 1
Manufacturer
Integra York, Pa Inc.Catalog number
XXX-SURGICAL CLAMP
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
SUS VOLUNTARY EVENT REPORT FOI FOR MANUFACTURERS (MW5088583) WAS RECEIVED ON (B)(6) 2019 WITH THE FOLLOWING INFORMATION: ON (B)(6) 2019, A PATIENT WAS PRESENTED FOR AN ELECTIVE RIGHT TOTAL KNEE ARTHROPLASTY. DURING THE PROCEDURE, THE TIP OF A RIGHT ANGLE SURGICAL CLAMP WAS BROKEN. THE TIP WAS IMMEDIATELY RETRIEVED BY THE PROVIDER. NO PATIENT HARM WAS REPORTED. THERE WAS NO OTHER INFORMATION PROVIDED.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED FOR EVALUATION. A FAILURE ANALYSIS AND DETERMINATION OF ROOT CAUSE IS NOT POSSIBLE DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED. THE REPORTED COMPLAINT IS UNCONFIRMED.
Description of Event or Problem
N/A.