FDA Adverse Event Injury Summary report: N

TROCAR SETS FOR VITREORETINAL SURGERY

MDR report key: 12025395 · Received June 18, 2021

Report

Report Number: 0001920664-2021-00072
Event Type: Injury
Date Received: June 18, 2021
Report Date: May 20, 2021
Manufacturer: STERIMEDIX LIMITED
Product Code: HMX
PMA / PMN Number: EXEMPT
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: HU
Reporter Occupation: OTHER
Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

TESTING WAS PERFORMED ON THE PENETRATION FORCE FOR THIS BATCH COMBINED WITH THE CANNULA AGAINST THE PENETRATION FORCE OF A CONFORMING BATCH THAT WAS RETAINED BY THE MANUFACTURER. THE PENETRATION FORCE WAS FOUND TO BE HIGHER IN THE REPORTED LOT. THE MEAN OF 2.5 NEWTONS VS 2 NEWTONS. DESPITE MULTIPLE ATTEMPTS TO OBTAIN THE VENDOR INVESTIGATION RESULTS, NO FURTHER INFORMATION HAS BEEN PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS (DHR) FOUND NO ANOMALIES, DEVIATION OR NON-CONFORMANCES FOR THIS LOT. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem · 1

A USER FACILITY IN (B)(6) REPORTED THAT THE TROCARS WERE VERY HARD TO INTRODUCE INTO THE EYE AND FOLLOWING REMOVAL DID NOT CLOSE THE WOUND SUFFICIENTLY. ADDITIONAL SUTURING HAD TO BE APPLIED. THERE WERE NO INJURIES TO THE PATIENTS. BASED ON THE INFORMATION PROVIDED, THE NUMBER OF PATIENTS AND USER FACILITIES INVOLVED ARE UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
920159	TROCAR SETS FOR VITREORETINAL SURGERY	CANNULA, OPHTHALMIC	HMX	STERIMEDIX LIMITED	M4510	222

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Required Intervention