MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA STERISEAL 27G HYDRODISSECTION VE CURVED .40MM X 22MM CANNULA; OPHTHALMIC CANNULA

Model Number 2273D00

Device Problem Detachment Of Device Component (1104)

Patient Problem Injury (2348)

Event Date 06/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported on ref 172118 that the needle shot from the luerlock into the eye during surgery.No direct material damage was noticed to the material used.The item was in use at the time of the alleged malfunction, injury reported.What is the current status of the patient? the injury is resolved by performing a second surgery.What surgery/procedure was being performed? cataract procedure - closing incision.Please describe the details of the procedure just prior to the cannula detaching from the luer-lock syringe and directly after.During the same procedure, before the detachment, the needle/syringe was used 3 times.During the procedure the needle/syringe was not screwed or refilled.When using the needle/syringe for the 4th time during the procedure, the needle shot of the syringe into the eye of the patient.No extreme pressure was felt.Is the cannula and syringe routinely tested prior to use? don¿t know.Did the detaching cause any injury to the patient? if yes, please describe injury and any treatment provided.Capsular rupture and cv bleeding.Treatment : new surgery.

Manufacturer Narrative

Six samples were provided from the user facility.Samples were tested per iso 594-1 and passed.The cannulas were then attached to a water filled syringe and pressure was applied to the plunger.All six cannulas were tested multiple times replicate the needle 'shooting' off the syringe without the use of excessive force.The failure could not be replicated.The syringe that was in use at the time of the failure was requested, but not provided.All six cannulas did not show any damage and passed functional testing during investigation.

Event Description

Customer reported on ref 172118 that the needle shot from the luerlock into the eye during surgery.No direct material damage was noticed to the material used.The item was in use at the time of the alleged malfunction, injury reported.1.What is the current status of the patient? the injury is resolved by performing a second surgery.2.What surgery/procedure was being performed? cataract procedure - closing incision.3.Please describe the details of the procedure just prior to the cannula detaching from the luer-lock syringe and directly after.During the same procedure, before the detachment, the needle/syringe was used 3 times.During the procedure the needle/syringe was not screwed or refilled.When using the needle/syringe for the 4th time during the procedure, the needle shot of the syringe into the eye of the patient.No extreme pressure was felt.4.Is the cannula and syringe routinely tested prior to use? don¿t know.5.Did the detaching cause any injury to the patient? if yes, please describe injury and any treatment provided.Capsular rupture and cv bleeding.Treatment : new surgery.

• Brand Name: STERISEAL 27G HYDRODISSECTION VE CURVED .40MM X 22MM CANNULA
• Type of Device: OPHTHALMIC CANNULA
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: megan morrissey ; 6945 southbelt dr. s.e.; caledonia, MI 49316
• MDR Report Key: 6727643
• MDR Text Key: 80516431
• Report Number: 1836161-2017-00070
• Device Sequence Number: 1
• Product Code: HMX
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2273D00
• Device Lot Number: 125519, 106197, 114028, 118525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention