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

Catalog Number 705.44P

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

A sample is available that has not yet been received at 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 nurse reported that an ophthalmic forceps device could not be loosened after pressing during vitrectomy surgery.An alternate forceps device was obtained in order to complete the procedure.There was no impact to the patient.Additional information has been requested.

Manufacturer Narrative

A forceps sample, protected in bubble wrap, was received with the original inner blister.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 with various magnifications.The customer¿s complaint was confirmed.It was found that the tube is loose.The complaint history was reviewed two years back which showed comparable complaints as to the reported issue.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.It resulted that the metal tubes may loosen due to an improperly performed bonding procedure.Based on the available data, this is a single event for this finished product lot and sub-assembly lot.A design related root cause for the damage of the complained device has not been identified.No further actions are necessary.(b)(4).

• Brand Name: GRIESHABER REVOLUTION DSP 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7084531
• MDR Text Key: 94410753
• Report Number: 3003398873-2017-00029
• Device Sequence Number: 1
• Product Code: HNR
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 705.44P
• Device Lot Number: F132892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2015
• 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
• Patient Outcome(s): Other