GIA PREMIUM
Received Jun 8, 2018 · Event occurred May 23, 2018
Report 2647580-2018-02771 · MDR key 7582591
Device
Generic name
Apparatus, Suturing, Stomach And Intestinal
Manufacturer
Us Surgical Puerto RicoModel number
030735LCatalog number
030735L
Lot number
P7K1548X
Product problems
- Failure to Form Staple
- Failure to Form Staple
Patient
Not reported
- Failure to Anastomose
- No Code Available
- Failure to Anastomose
- No Code Available
Narrative
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 AN OPEN LEFT-SIDED HEMICOLECTOMY PROCEDURE, WHILE DOING THE SIDE-TO-SIDE ANASTOMOSIS, THE KNIFE DID NOT CUT THE TISSUE BETWEEN THE ROWS OF STAPLES ON ONE SIDE ONLY. IT CLOSED ONE SIDE WITH DENSELY 4 ROWS OF STAPLES AND THE OTHER LEFT OPEN. TIME OF SURGERY EXTENDED OVER 30 MINUTES WITH LOSS OF ADDITIONAL TISSUE DUE TO DEFECT AND MANUAL ANASTOMOSIS WAS DONE. THE EVENT ALSO LEAD TO EXTENDED HOSPITALIZATION OF 8 DAYS.