MAUDE Adverse Event Report: BAUSCH + LOMB STORZ INSTRUMENT; SIM

Model Number E4971

Device Problem Particulates (1451)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/06/2016

Event Type  Injury  

Manufacturer Narrative

Based on all information, no causal factors can be determined and no conclusion can be drawn.

Event Description

The user facility reported a piece of metal fleck got into a patient's eye during a cataract surgery.The surgeon inspected the b+l simcoe instrument being used, part number e4971, and saw metal particles in the tube.The b+l part was purchased from buffalo supply in august, 2015.Additional information: the particulate was not removed from the patient's eye.There has been no added medical treatment.

Manufacturer Narrative

Evaluation completed.One e4971 23ga i/a unit was returned in a plastic bio-hazard bag.The original packaging was not returned.Visual inspection found the assembly dirty with particulates and solutions all over it.Water was injected through the irrigation cannula out the tip of the port onto a 0.45 micron filter.The water was vacuumed off through the filter in an attempt to trap any possible particles.Microscopic examination of the filter found many very small particles and several blue fiber-like particles.None of the particles had the appearance of metal.However, the filter was sent to the lab for particulates analysis.The instrument was sent to manufacturing for further evaluation.The lab results were received and state "these analyses indicate that the small dark colored particles consist of silicon, chromium, sulfur, magnesium, and aluminum.The particles are very small (approximately 20 microns).The composition and appearance of the particles would suggest that they are composed of a mineral compound, as opposed to a particle of a metallic alloy." the instrument was further inspected under 200x microscopic magnification.A material that appeared to be foam was found in the lumen.This material does not match anything used in the fabrication, packaging, or transportation of this instrument.Inventory was checked.Four samples were inspected for this issue with no rejections.

• Brand Name: STORZ INSTRUMENT
• Type of Device: SIM
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 499 sovereign court; manchester MO 63011
• Manufacturer Contact: sharon spencer ; 50 technology drive west; irvine, CA 92618 ; 949398-569
• MDR Report Key: 5681470
• MDR Text Key: 45969625
• Report Number: 0001920664-2016-00177
• Device Sequence Number: 1
• Product Code: HNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: E4971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other