EVA TDC VITRECTOMY PACK VGPC INPUT 25G
Received Jan 11, 2019
Report 1222074-2019-00007 · MDR key 8241045
Device
Generic name
Ophthalmic Surgical Procedure Kit, Non-medicated, Single-use
Catalog number
8310.25G02
Lot number
2000395330
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
INVESTIGATION WILL START AS SOON AS PRODUCT IS RECEIVED. FOLLOW UP (B)(6) 2019: INVESTIGATION COULD NOT BE STARTED AS PRODUCT WAS NOT RECEIVED BY DORC YET. CUSTOMER INDICATED THAT THE AFFECTED PRODUCT WAS SENT TO D.O.R.C. ON FRIDAY (B)(6) 2019. INVESTIGATION WILL START AS SOON AS PRODUCT IS RECEIVED.
Description of Event or Problem
HYPOTONIA DURING THE VITRECTOMIE.
Additional Manufacturer Narrative
TEXT RECEIVED FROM CUSTOMER: HYPOTONIA DURING THE VITRECTOMIE. INVESTIGATION WILL START AS SOON AS PRODUCT IS RECEIVED.
Description of Event or Problem
HYPOTONIA DURING THE VITRECTOMIE.
Additional Manufacturer Narrative
THE AFFECTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION, DESPITE SEVERAL ATTEMPTS TO LOCATE IT WITHIN THE LOGISTIC CHAIN. SUBSEQUENT TO THE INITIAL REPORT, DORC HAS BEEN WORKING TO CLARIFY THE CIRCUMSTANCES OF THE ISSUE WITH THE CUSTOMER. DORC WAS INFORMED BY THE DORC AREA SALES MANAGER THAT AFTER CONSULTING THE SURGEON, IT WAS THEIR OPINION THAT THE LACK OF INFUSION WAS NOT CAUSED BY THE ALLEGED DEFAULT OF THE PACK. A REVIEW OF THE SETTINGS UTILISED FOR SURGERY INDICTED THAT THE INFUSION LEVEL IN THE SURGICAL STEP "VITRECTOMY PERIPHERIQUE" WAS POTENTIALLY TOO LOW IN THE CASES CONCERNED AND MAY HAVE CONTRIBUTED TO THE HYPOTONY. THE SURGEON HAS NOW ADJUSTED THE SURGICAL PARAMETERS AFTER SEVERAL SURGERIES NO OTHER ISSUES OCCURRED. THE EVA SURGICAL SYSTEM IS REQUIRED TO OFFER A FULL RANGE OF PRESSURE SETTINGS FOR SURGEONS, INCLUDING LOWER PRESSURE SETTINGS FOR CLINICAL SITUATIONS WHERE THIS APPROPRIATE. AS NO DEVICE MALFUNCTION HAS BEEN IDENTIFIED, NO CORRECTIVE ACTION IS IDENTIFIED.
Description of Event or Problem
HYPOTONIA DURING THE VITRECTOMIE.