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

Catalog Number	705.52
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No sample has been received at 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 a tip of scissors was broken in the patient's eye during a vitrectomy procedure.The procedure was completed by replacing the scissor with another one.There was no patient harm.
Additional Manufacturer Narrative
The received sample was found in opened original packaging including cover foil.One blade is broken off but included in gauze.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 received instrument was investigated.It was obvious that the scissor blade was broken.The cross section of the fracture was investigated more detailed.The fracture surface did not show signs of corrosion.Further signs indicating the cause of the fracture were not found during the investigation.A 100% functional test is performed during production, which ensures that the instrument fulfills the specification before it will be delivered.Therefore, it can only be assumed that issue was caused afterwards during handling, but this cannot be verified.No root cause identified as no signs were found indicating the cause of the fracture.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
• Common Device Name: SCISSORS, OPHTHALMIC
• MDR Report Key: 11958558
• Report Number: 3003398873-2021-00038
• Device Sequence Number: 11650372
• Product Code: HNF
• UDI-Device Identifier: 07612717064638
• UDI-Public: 07612717064638
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2021

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: 06/30/2021
• Device Catalogue Number: 705.52
• Device Lot Number: F167776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 09/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2018
• 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