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

Catalog Number 725.52P

Device Problem Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A sample is available that has not yet been received at manufacturing for evaluation.The device history record for the affected lot was reviewed.No abnormalities that could have contributed to this event were found in the production documentation and the sample was released according to acceptance criteria.A 100% final inspection is performed for this product.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 physician reported that an ophthalmic scissors tip would not open prior to surgery.An alternate scissors tip was obtained in order to perform and complete the procedure.There was no involvement between the patient and the unsatisfactory scissors therefore, there is no patient impact associated with this reported event.

Manufacturer Narrative

Additonal information is provided in sections d.10, g.1, g.2, h.3, h.6 and h.10.The received scissors sample was found in the opened original packaging including cover foil.The sample was sent back well packed.The received instrument showed no signs of use, but was open before the investigation was started.To perform the investigation, the advanced tip was opened by removing the cap.This opening procedure broke the advanced tip so that the tip mechanism could not be opened further more.Activation of the instrument could not be performed with a standard handle anymore.The mechanism was investigated by activating manually with a pin.High friction between the moving tube and the scissors insert was able to be felt while activating.Moving slowly let the tube stick when the scissors inserts was still closed.Therefore, the customer's complaint was confirmed.A 100% inspection of the friction during production is performed to ensure that an instrument with too much friction and the risk to stick would not pass the test.A root cause of the high friction could not be determined.The scissor insert showed no abnormal signs even in the reconstructed situation.Therefore, no production issue can be detected whether for the insert nor for the complete instrument.A manufacturing or design related root cause for the damage of the complained device has not been identified.No further actions will be taken.The manufacturer internal reference number is: (b)(4).

• Brand Name: GRIESHABER ADVANCED DSP TIP SCISSORS
• Type of Device: SCISSORS, OPHTHALMIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• MDR Report Key: 9109320
• MDR Text Key: 182336183
• Report Number: 3003398873-2019-00073
• 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
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 725.52P
• Device Lot Number: F165168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1