MAUDE Adverse Event Report: ALCON GRIESHABER AG CURVED MEMBRANE SCRAPER; SPATULA, OPHTHALMIC

Catalog Number	338.25P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
A nurse reported that the flex loop of an ophthalmic membrane scraper device broke while inside of the patient's eye during surgery.An alternate scraper was obtained in order to complete the procedure.There was no harm to the patient.
Additional Manufacturer Narrative
The previous report submitted for this event contained an error in h1.¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h1.On a select number of reports.The error, which was limited only to the h1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The received sample was found without the inner and outer blister however, the cover foil was included.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 returned instrument has been investigated and showed a broken flex loop, but there was no evidence to a possible root cause.The instrument did not show any signs of external force that would have caused such a fracture.In production, a 100% inspection of the instrument is performed which would identify a broken flex loop.Therefore, it can be excluded that the instrument left production with a broken loop.It is known that the reported instrument has to be inserted according to the description in the directions for use (dfu).If that instruction is not followed, the instrument will be destroyed inside of the trocar.It cannot be proven anymore how the instrument was inserted, but this could be a possible root cause to break the devices flex loop.Root cause for the broken flex loop was unable to be verified.This device passed the 100% control and was conforming when leaving the production.This complaint has been reviewed and future data will be monitored for evidence of adverse trending with further action 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: CURVED MEMBRANE SCRAPER
• Common Device Name: SPATULA, OPHTHALMIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• MDR Report Key: 11399910
• Report Number: 3003398873-2021-00013
• Device Sequence Number: 16920556
• Product Code: HND
• UDI-Device Identifier: 07612717071445
• UDI-Public: 07612717071445
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 338.25P
• Device Lot Number: F199952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 03/03/2021; 04/16/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 03/18/2021; 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1