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

Catalog Number 705.52P

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 01/24/2019

Event Type  Injury  

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.Additional information has been requested.(b)(4).

Event Description

A customer reported that an ophthalmic scissors failed in the open position during surgery.The entry trocar had to be removed and the incision was extended in order to remove the scissors while in the opened position.The procedure time was extended and a suture was required for the extended incision.Additional information received confirmed that the patient issue has resolved.

Manufacturer Narrative

The received scissors sample was found bent in the outer blister including cover foil.Surgery residuals were visible.The tip was very bent.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 sample was visually inspected with the aid of a photomicroscope and with various magnifications.The sample was bent by external force.Before and after cleaning, the sample could be activated, but the scissors would not close.Due to the very bent condition of the instrument and tip, it is not possible to determine a root cause or investigate the reported issue.The sample was not returned properly and was probably additionally damaged during transport.The root cause for the reported event could not be determined conclusively.The most possible root cause is external force.A manufacturing or design related root cause for the damage of the complained device could not been identified.The manufacturer has no influence on complaints which are in relation to external force.No further actions will be issued.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: 8324729
• MDR Text Key: 135677508
• Report Number: 3003398873-2019-00009
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 705.52P
• Device Lot Number: F136844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TROCAR, UNSPECIFIED
• Patient Outcome(s): Other
• Patient Age: 57 YR