MAUDE Adverse Event Report: BAUSCH & LOMB, INC. STORZ SIMCO DOUBLE BARRELED I/A UNIT 23G; HAND HELD SURGICAL INSTRUMENT

Catalog Number E4971

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/18/2014

Event Type  malfunction  

Event Description

The user facility reported the irrigating aspirating cannula was oxidizing when sterilized.They reported visible tarnishing of the instrument, black under the silver, and it had been flaking into the patient's eyes.Additional information was received from the circulating rn who reported there was no patient impact reported to her concerning this instrument.

• Brand Name: STORZ SIMCO DOUBLE BARRELED I/A UNIT 23G
• Type of Device: HAND HELD SURGICAL INSTRUMENT
• Manufacturer (Section D): BAUSCH & LOMB, INC.; rochester NY 14609
• Manufacturer Contact: sharon spencer, director ; 50 technology; irvine, CA 92618 ; 9493985698
• MDR Report Key: 3979265
• MDR Text Key: 16632762
• Report Number: 1920664-2014-00123
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: E4971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2014
• 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