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

Catalog Number	338.27
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
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 physician reported that an ophthalmic scraper control button would not operate which prevented the nitinol loop from extending during retinal surgery thus, preventing the device from scraping properly.An alternate scraper was obtained in order to complete the procedure.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.Sample was not received by the investigation site for evaluation.The root cause cannot be identified conclusively because no picture or sample has been received.Investigation has been completed based on current information.Should sample returned, this file will be re-opened and failure analysis will be performed.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).
Additional Manufacturer Narrative
The investigation is completed.Customer reported finesse loop control button was not working properly.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 the sample was visually inspected with the aid of a photomicroscope with various magnifications.The sample was functionally inspected.The customer¿s complaint was not confirmed.It was found that the control button of the device was working.No loop was present (also see microscopic images prior to cleaning).When the loop disappeared can no longer be determined.The root cause cannot be identified conclusively because the sample has pass the 100% inspection.The sample was received in a closed status.As the blister was opened by the customer, he handled the product.The point in time when the malfunction occurred, can no longer be determent.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: 12606043
• Report Number: 3003398873-2021-00077
• Device Sequence Number: 13806400
• Product Code: HND
• UDI-Device Identifier: 07612717071452
• UDI-Public: 07612717071452
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2022

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: 08/31/2022
• Device Catalogue Number: 338.27
• Device Lot Number: F182187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 11/29/2021; 05/05/2022
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 12/20/2021; 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2019
• 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