MAUDE Adverse Event Report: SYNERGETICS STIFF 25G TANO DIAMOND DUSTED MEMBRANE SCRAPER; INSTRUMENT, MICROSURGICAL

Model Number 20.04.25S

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2022

Event Type  malfunction  

Manufacturer Narrative

The product evaluation has been completed.The product handle/shaft assembly was returned in a generic zip top bag.The broken off tip of the device was not included.Visual inspection confirmed the abrasive silicone bead was broken off at the end of the shaft.This is a known potential issue and is addressed in our instructions for use document (b)(4) rev m included with the product.Therefore, the most probable root cause was determined to be user error.The device history was reviewed and found to meet manufacturing specifications.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.

Event Description

It was reported that the tip of the diamond dusted membrane scraper came off of the rubber while in the patient's eye.The doctor was able to remove the tip with forceps.The patient was not injured.

• Brand Name: STIFF 25G TANO DIAMOND DUSTED MEMBRANE SCRAPER
• Type of Device: INSTRUMENT, MICROSURGICAL
• Manufacturer (Section D): SYNERGETICS; 3845 corporate centre dr.; o''fallon MO 63368
• Manufacturer (Section G): SYNERGETICS; 3845 corporate centre dr.; o''fallon MO 63368
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 15627399
• MDR Text Key: 302791188
• Report Number: 0001920664-2022-00141
• Device Sequence Number: 1
• Product Code: GZX
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20.04.25S
• Device Catalogue Number: 20.04.25S
• Device Lot Number: M0043300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2022
• Is the Reporter a Health Professional?: Yes
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: STELLARIS UNIT AND ACCESSORIES