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

Catalog Number 705.52P

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2023

Event Type  malfunction  

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 Description

A customer reported that an ophthalmic scissors tip was broken and one side fell into the patient's eye.There was no patient harm caused as the surgeon was able to retrieve it with no additional surgical procedure needed.

Manufacturer Narrative

A customer reported that the tip of a 25+ revolution dsp scissors broke off and fell into the patient's eye.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 sample was received in its inner blister but without outer blister or the cover foil.The sample shows substantial damage: the tip/tube component is torn off from the handle and the scissors insert is missing completely.Several lamellae of the basket on the handle are broken or deformed significantly.The state of the sample does not correlate with the image provided in the quality summary (qs).This is in line with the extent of the sample damage, indicating that the sample was already subjected to a tampering after the malfunction and before being returned to the investigation site.A root cause analysis can therefore not be performed on the sample.Based on the images attached to the qs, the damage is confirmed.Due to the state of the device, no root cause could be identified by this investigation.It cannot be determined how or where the damage to the sample occurred; therefore a root cause for the customers reported event could not be determined.The exact root cause for the customers reported event is unknown, therefore, specific action cannot be taken.Complaints are reviewed and monitored at regular intervals for adverse trends.No adverse trends have been observed associated with the reported product and event.No action has been identified for this reported event.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
• Manufacturer (Section G): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17650105
• MDR Text Key: 322273516
• Report Number: 3003398873-2023-00178
• Device Sequence Number: 1
• Product Code: HNF
• UDI-Device Identifier: 07612717070691
• UDI-Public: 07612717070691
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 705.52P
• Device Lot Number: 150YP0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1