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

Catalog Number 705.52P

Device Problem Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No sample has been received by manufacturing for evaluation.The investigation is in progress.The device history record for the affected lot number was reviewed.No abnormalities that could have contributed to this event were found in the production documentation and the sample was released according to the manufacturer's 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.Additional information has been requested.(b)(4).

Event Description

A doctor reported that an ophthalmic scissor tip was stuck with no action during surgery, but prior to any patient involvement.An alternate scissor tip was obtained in order to begin the procedure.Additional information has been requested.

Manufacturer Narrative

Corrected information is provided in brand name and model #/ lo # to clarify that the catalog number provided on the initial report was incorrect.The correct part number will be provided once the investigation has been completed.(b)(4).

Manufacturer Narrative

A scissors sample was received by manufacturing with the original outer and inner blister including cover foil.The sample was visually inspected with the aid of a photomicroscope and with various magnifications.The scissors blade was broken.The instrument was destroyed in order to investigate why the blade broke off.The complaint history was reviewed two years back.It showed no comparable complaints.Per the manufacturing science and technology evaluation, the scissor blade was broken on an untypical position.Stresses in the scissors insert are most high at the end of the electrical discharge machining process cut, but the investigation showed that the scissors blade was broken there.The scissor blade was broken between the tip of the scissors and the end of the electrical discharge machining process cut.Since the scissor blade was not broken on the position with the most high stresses, the reason for the fracture had to be investigated.On the outer side of the scissor blades were signs of corrosion visible.The analysis of the cross section showed that the corrosion was entered into the scissor blade.The high stresses during activation led to the fracture of the scissor blade.A more detailed picture of the cross section shows how far corrosion already affected the scissor blade.The fine dark gray surface structure shows the corrosion is of the cross section.The rough surface (light gray) indicates where the cross section was not affected by corrosion.It can be concluded that corrosion led to the fracture of the scissor blade.Why the scissor started to corrode cannot be determined anymore.Corrosion affects the insert over time.However, the instrument passed all internal inspections.An insufficient process can be excluded since this complaint is a single case.Corrosion on a disposable instrument is very untypical.A re-use cannot be confirmed but not excluded.No injuries have been reported or are expected related to this issue.A manufacturing or design related root cause for the damage of the complained device has not been identified.Based on the complaint history the complaint represents a single event.No further actions will be issued.(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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 5967157
• MDR Text Key: 55615449
• Report Number: 3003398873-2016-00016
• Device Sequence Number: 1
• Product Code: HNF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Catalogue Number: 705.52P
• Device Lot Number: F112801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2014
• 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