MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY INC. SEIBEL CAPSULORHEXIS FORCEPS, SHARP; FORCEPS, OPHTHALMIC

Model Number	DEMO DFH-0030
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Tip broke off in the patient's eye.

• Brand Name: SEIBEL CAPSULORHEXIS FORCEPS, SHARP
• Common Device Name: FORCEPS, OPHTHALMIC
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY INC.; 8415 154th ave ne; redmond WA 98952
• Manufacturer (Section G): MICROSURGICAL TECHNOLOGY INC.; 8415 154th ave ne; redmond WA 98052
• Manufacturer Contact: jeffrey cody ; 8415 154th ave ne; redmond, WA 98052
• MDR Report Key: 17394128
• Report Number: 3019924-2023-00005
• Device Sequence Number: 15346368
• Product Code: HNR
• UDI-Device Identifier: 00844685001484
• UDI-Public: 00844685001484
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DEMO DFH-0030
• Device Catalogue Number: DEMO DFH-0030
• Device Lot Number: 080790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown