MalfunctionOVN
MDR event
Received Jul 11, 2018
Report 1219930-2018-03758 · MDR key 7679299
Device
Product problems
- Break
- Disconnection
- Break
Patient
24 YR
- No Known Impact Or Consequence To Patient
- No Code Available
- No Known Impact Or Consequence To Patient
- No Code Available
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, DURING THE PROCESS OF SUTURING AND LIGATING THE PATIENT, THE ABSORBABLE SURGICAL SUTURE WAS DISCONNECTED SUDDENLY. THE THREAD WAS REMOVED IMMEDIATELY AND THE SUTURE WAS REPLACED AND RE-STITCHED. THEY REPLACED AND REPORTED THE SAMPLE.