MAUDE Adverse Event Report: CAREFUSION INC. SNOWDEN-PENCER DIAMOND-FLEX RETRACTOR

Model Number	89-6112
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Activation Problem (4042)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
V.Mueller contacted the user facility to obtain additional event information and is awaiting a response.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported via medwatch # (b)(4) that, "wire was noticed to be frayed and the instrument was removed from the inside of the patient." no report of injury.
Additional Manufacturer Narrative
The snowden-pencer diamond-flex retractor subject of the reported event was returned for evaluation.Upon visual inspection it was found that the tension cable was severed, and the device was unable to articulate.There was a bend in the main shaft of the device and a sharp bend in the memory wire.The braided cables within the sharp bend of the memory wire were also fractured.The snowden-pencer diamond-flex retractor subject of the reported event is 19 years old.A complaint review has determined this to be an isolated event for the subject lot.No additional issues have been reported.

• Brand Name: SNOWDEN-PENCER DIAMOND-FLEX RETRACTOR
• Common Device Name: SNOWDEN-PENCER DIAMOND-FLEX RETRACTOR
• Manufacturer (Section D): CAREFUSION INC.; 5 sunnen drive; maplewood MO 63143
• Manufacturer (Section G): CAREFUSION INC.; 5 sunnen drive; maplewood MO 63143
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 18961687
• Report Number: 1923569-2024-01006
• Device Sequence Number: 15290917
• Product Code: GCJ
• UDI-Device Identifier: 10885403122835
• UDI-Public: 10885403122835
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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: 89-6112
• Device Catalogue Number: 89-6112
• Device Lot Number: L05
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown