MAUDE Adverse Event Report: ALCON GRIESHABER AG GRIESHABER ADVANCED DSP TIP SCISSORS; SCISSORS, OPHTHALMIC

Catalog Number 725.52P

Device Problems Break (1069); Entrapment of Device (1212); Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

The device history record for the affected lot was reviewed.No abnormalities that could have contributed to this event were found and the product was released according to manufacturer's acceptance criteria.The manufacturer performs a 100% final inspection for this product.The received information indicates that the device was reused.This is a off-label use and is considered as user error.The manufactured product is provided sterile and is intended for single use.The instrument is a sterile single use device and shall not be reused.Potential risk from reuse or reprocessing include: reduced cutting or grasping performance, and foreign particle introduction into the eye.The packaging indicates also that this device should not been reused.Reuse of a non reusable device is a use error.The dfu was not followed.(b)(4).

Event Description

A surgeon reported that during a traumatic cataract extraction procedure a micro scissor was used to try to cut the anterior capsule.One of the blades broke off and fell into the vitreous cavity.The patient was sent to a vitreoretinal specialist for removal and implantation of the intraocular lens.It was noted that this scissor was sterilized and reused.Additional information has been received indicating the patient was taken to an adjoining room where the retinal specialist removed the blade.No vitrectomy was required.

• Brand Name: GRIESHABER ADVANCED DSP TIP SCISSORS
• Type of Device: SCISSORS, OPHTHALMIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer (Section G): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer Contact: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 9279031
• MDR Text Key: 165085890
• Report Number: 3003398873-2019-00088
• Device Sequence Number: 1
• Product Code: HNF
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 725.52P
• Device Lot Number: F165166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR