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

Catalog Number 705.52P

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2018

Event Type  malfunction  

Manufacturer Narrative

A sample is available that has not yet 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 Description

A nurse reported that an ophthalmic scissors device could not reopen after it had performed cutting.Procedure details are unknown.There was no impact to the patient.Additional information received clarified that the scissor could not reopen after testing the cutting prior to surgery.An alternate scissors was obtained in order to begin and complete the procedure.

Manufacturer Narrative

Additional information is provided.Corrected information is provided in section for the date that the sample was received at manufacturing which should have been provided at the time of the initial mdr.The received scissors sample was found in the opened, original packaging including cover foil.The sample is slightly bent and shows signs of use due to surgery residuals.The device history record for the affected lot was reviewed.No abnormalities that could have contributed to this event were found and the product was released according to acceptance criteria.A 100% final inspection is performed for this product.The complaint history was reviewed two years back.It showed 16 comparable complaints as to the damage.The sample was functionally and visually inspected with the aid of a photomicroscope with various magnifications.The customer¿s complaint was confirmed.The first inspection of the instrument showed that the insert and the extension tube was not fixed in the handle.The destructive testing showed that the production process was performed correctly.All connections between the insert extension tube and the instrument showed that glue was applied.These connections worked appropriately since the instrument could not have been adjusted without problems at production.Why the insert dislocated out of the instrument cannot be determined anymore.The retrieved instrument cannot pass the final inspection in production since the functionally tests and the visual tests cannot be passed according to inspection plan (b)(4).To ensure a strong connection between the extension tube and the adjustment screw, a gluing test with the tubes has to be performed after cleaning for each tube batch.The tested tubes have to be used in production within two weeks.After the two weeks, the gluing test has to be repeated.The quality of the glue is proven according to the operating procedure aa001.123 which is defined for all tests performed for the glue.A design related root cause for the damage of the complained device has not been identified.Based on the results of the product evaluation, no further actions are necessary.The manufacturer internal reference number is: (b)(4).

• Brand Name: GRIESHABER REVOLUTION DSP SCISSORS
• Type of Device: SCISSORS, OPHTHALMIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• MDR Report Key: 7801266
• MDR Text Key: 118091802
• Report Number: 3003398873-2018-00026
• Device Sequence Number: 1
• Product Code: HNF
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 705.52P
• Device Lot Number: F134061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Date Manufacturer Received: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other