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

Catalog Number 706.52

Device Problems Break (1069); Material Separation (1562); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2020

Event Type  malfunction  

Manufacturer Narrative

No sample has been received by 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.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that one of the tips of an ophthalmic scissors broke and stopped working during surgery and, upon removal from the eye, the tip further separated and broke off.There was no harm to the patient.Additional information received further clarified that the scissors stopped working during an infantile cataract procedure with posterior capsular plaque.An alternate scissors was obtained in order to complete the procedure.

Manufacturer Narrative

One forceps sample was received in an outer blister including the cover foil.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The sample was visually inspected with the aid of a photomicroscope with various magnifications.It was found that one scissors blade is broken off and the other is bent.Due to the position of the bent blade, it was concluded that external force during user handling damaged the device and broke the other blade off.Root cause is external force during handling.A manufacturing or design related root cause for the damage of the complained device has not been identified.This complaint has been reviewed and future data will be monitored for evidence of adverse trending and further action will be taken, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis.The manufacturer internal reference number is: (b)(4).

• Brand Name: GRIESHABER REVOLUTION DSP SCISSORS
• Type of Device: SCISSORS, OPHTHALMIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• MDR Report Key: 10479580
• MDR Text Key: 206310587
• Report Number: 3003398873-2020-00101
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 706.52
• Device Lot Number: F160503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Date Manufacturer Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 5 MO