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

Catalog Number 725.52

Device Problems Failure to Cut (2587); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

A sample is available that has not yet been received at manufacturing for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

A physician reported that two ophthalmic scissors cut poorly and failed to open or close during vitrectomy surgery.An alternate scissors was obtained in order to complete the procedure.Patient impact information is unknown.

Manufacturer Narrative

Four unopened samples were received in an opened box.The samples were functionally inspected with the aid of a photomicroscope with various magnifications.Three of the instruments meet the specifications.One sample does not smoothly open and close and, due to this, the cutting is poor.The customer¿s complaint was confirmed.It resulted that the instrument does not smoothly open and close so the cutting is poor.The instrument has maybe been incorrectly adjusted.This is a single case so no other action will be taken.The device history record for the suspected lot was reviewed.No abnormalities that could have contributed to this event were found and the product was released according to acceptance criteria.A 100% final inspection is performed for this product.The insufficient adjustment could lead to a lack of functionality and has not been noticed during manufacturing.As it is a single event, no further actions will be defined.The manufacturer internal reference number is: (b)(4).

• Brand Name: GRIESHABER ADVANCED DSP TIP SCISSORS
• Type of Device: SCISSORS, OPHTHALMIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• MDR Report Key: 8417030
• MDR Text Key: 138952802
• Report Number: 3003398873-2019-00013
• Device Sequence Number: 1
• Product Code: HNF
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 725.52
• Device Lot Number: F160680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Date Manufacturer Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1