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

Catalog Number	725.52
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
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 customer reported that during a vitrectomy procedure, the scissors would not cut.A new tip was used to complete the case.There was no patient harm.
Additional Manufacturer Narrative
A review of the device history records traceable to the reported lot numbers indicates that the products were processed and released according to the product¿s acceptance criteria.No sample received.A root cause cannot be ascertained because the damage cannot be confirmed without receiving a sample for investigation.The sample is not available for investigation, therefore, damage cannot be confirmed or rather a root cause cannot be identified.Should sample return this complaint will be reopened and the sample will be investigated.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
Two samples were received in one tube.Unfortunately, it is not possible to determine, which sample belongs to which case, because they lost their labeling, most possible during transport.One sample is bent.Both samples show surgery residuals.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 two received sample were visually and functionally inspected with the aid of a photomicroscope with various magnifications.Customers complaint was not confirmed.Both samples are able to cut the test material.One sample is deformed.The other sample clamps, during testing.It is possible, that this is the reason why customer complained this device.Both instruments passed the test according to the test instructions.And therefore, passed the 100% cutting test and the 100% optical test.Why one scissor is clamping and the other is bent could not be determined conclusively.It is confirmed, that the two scissors are cutting.But the root cause for the clamping and the bend scissors was not determined.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 ADVANCED DSP TIP SCISSORS
• Common Device Name: SCISSORS, OPHTHALMIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• MDR Report Key: 11575333
• Report Number: 3003398873-2021-00023
• Device Sequence Number: 4352042
• Product Code: HNF
• UDI-Device Identifier: 07612717071063
• UDI-Public: 07612717071063
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2021

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 Catalogue Number: 725.52
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 04/08/2021; 06/23/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 04/29/2021; 07/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1