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

Catalog Number	338.27
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 physician reported that during a surgery tip of an ophthalmic micro scraper was stuck.The surgery was performed and completed after replacing the product with another one.There was no harm to the patient.
Additional Manufacturer Narrative
A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The sample is received with inner blister, outer blister and cover foil showing the lot information.The sample shows no macroscopic signs of damage.The sample shows no signs of surgery residues and is returned in closed state.Visual inspection was conducted with the aid of a photomicroscope using various magnifications.No loop is visible in the closed state.No resistance is felt by the extension of the loop.The loop is found bent and damaged.Due to the description of the fault, the damage to the loop was most likely introduced by the customer.What caused the initial struggle to pull the loop back can no longer be determined.The root cause cannot be identified conclusively as the loop actuated without resistance; the reported malfunction cannot be confirmed.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: CURVED MEMBRANE SCRAPER
• Common Device Name: SPATULA, 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: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13568673
• Report Number: 3003398873-2022-00008
• Device Sequence Number: 6062690
• Product Code: HND
• UDI-Device Identifier: 07612717071452
• UDI-Public: 07612717071452
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2022

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: 09/09/2020
• Device Catalogue Number: 338.27
• Device Lot Number: F199977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown