MAUDE Adverse Event Report: ALCON GRIESHABER AG FINESSE SHARKSKIN ILM FORCEPS; FORCEPS, OPHTHALMIC

Catalog Number 711.88

Device Problem Difficult to Open or Close (2921)

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

Event Date 09/11/2018

Event Type  malfunction  

Manufacturer Narrative

No sample has been received by 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 forceps tip was unable to be opened after it was closed during a cataract and vitrectomy surgery.An alternate forceps device was obtained in order to complete the procedure.There was no impact to the patient.Additional information is not available for this report.

Manufacturer Narrative

During the investigation, a deviation was found that should be in no relation to the complaint thus, no abnormalities which could have contributed to this event were found.A root cause cannot be ascertained because the damage cannot be confirmed without receiving a sample for investigation.The possible issue was investigated within deviation (b)(4).(b)(4).

• Brand Name: FINESSE SHARKSKIN ILM FORCEPS
• Type of Device: FORCEPS, 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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7901786
• MDR Text Key: 121713097
• Report Number: 3003398873-2018-00028
• Device Sequence Number: 1
• Product Code: HNF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 711.88
• Device Lot Number: F163445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1