MAUDE Adverse Event Report: ALCON GRIESHABER AG CONSTELLATION PNEUMATIC HANDPIECE; UNIT, PHACOFRAGMENTATION, ACCESSORY, HANDPIECE

Catalog Number 725.03

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 07/28/2020

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

Event Description

A physician reported that an ophthalmic pneumatic handpiece connecting part got detached before surgery and prior to insertion into an eye.An alternate pneumatic handpiece was obtained in order to begin and complete the procedure.There was no report of any patient involvement or patient harm.

Manufacturer Narrative

Additional information is provided in sections d.10, h.3, h.6 and h.10.One sample pneumatic handpiece was received in opened original packaging including the cover foil.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 pneumatic handpiece was sent back in the original blister.The fixation ring, fixed below the bayonet catch of the handpiece, was loose in the blister.The fixation ring is used to stabilize the advanced tip on the bayonet catch.Once the advanced tip is positioned on the bayonet catch, the fixation ring is turned on the thread to clamp the advanced tip on the bayonet catch.The thread of the fixation ring is, against standard, left hand threaded.If this is not well understood, the fixation ring can be detached before the advanced tip is fixed.To fix a detached fixation ring again on the handpiece, a mechanical resistance has to be overcome.This mechanical resistance is made in the design of the fixation ring to prohibit the ring turning off from the handpiece.The pneumatic handpiece was produced and inspected at the manufacturing site.The final inspection includes a specific 100% visual inspection of the fixation ring.Additionally, packaging is validated including transportation test.Therefore, it can be excluded that the instrument was delivered to customer with a loose fixation ring.Finally, the customer complaint can be confirmed as an appropriate fixation of the tip without fixation ring is not possible.The root cause of this issue cannot be attributed to production, inspection or transportation.The root cause could be determined to be user handling.The fixation ring was turned wrong on the thread which clamps the advanced tip on the bayonet catch.The correct handling of advanced tip fixation on the bayonet catch and the use of the fixation ring is described in the corresponding directions for use (dfu) delivered with the pneumatic handpiece.This complaint has been reviewed and future data will be monitored for evidence of adverse trending and further action will be taken, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION PNEUMATIC HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION, ACCESSORY, HANDPIECE
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• MDR Report Key: 10404225
• MDR Text Key: 203640478
• Report Number: 3003398873-2020-00085
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K063583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 725.03
• Device Lot Number: F158213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1