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

Catalog Number 705.52P

Device Problem Difficult to Open or Close (2921)

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

Event Date 04/12/2019

Event Type  malfunction  

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.(b)(4).

Event Description

A nurse reported that an ophthalmic forceps could not be opened prior to surgery.An alternate forceps was obtained in order to begin and perform the procedure.There was no patient impact associated with this reported event.

Manufacturer Narrative

The received forceps sample was found in the opened original packaging including cover foil.Due to surgery residuals, it can be concluded that it was used.The sample was visually inspected with the aid of a photomicroscope with various magnifications.The customer¿s complaint was confirmed.It was found that the tube is loose and blocks the forceps from activating.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 which showed comparable complaints.No adverse trend was observed.It cannot be excluded that the metal tube loosened and therefore, a proper activation was no longer possible.This kind of damage was already detected and investigated.The root cause could not be identified conclusively, but the most likely root cause can be determined to be an improperly performed bonding procedure.Based on the available data this is a single event for this finished product lot.The currently valid risk analysis considers the possible risks related to the reported event.With this case and related complaints within a time range of 24 months, the likelihood of occurrence of the hazard that may cause a patient harm is assessed in the risk management report.The final risk is considered as low.The residual risk remains unchanged and at acceptable level.Future data will be monitored for evidence of adverse trending and further action will be taken, as appropriate.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

• Brand Name: GRIESHABER REVOLUTION DSP FORCEPS
• Type of Device: SCISSORS, OPHTHALMIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• MDR Report Key: 8553347
• MDR Text Key: 143389616
• Report Number: 3003398873-2019-00032
• 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,Followup
• Report Date: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• 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: 705.52P
• Device Lot Number: F167692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1