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

Model Number	89-6112
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A lot number was not provided in medwatch # (b)(4), for the snowden-pencer device subject of the reported event.(b)(6), requested the device subject of the reported event be sent back for evaluation however, the device has not been returned.Without the evaluation or return of the subject device, a root cause cannot be determined.A follow-up report will be submitted should additional information become available.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch # (b)(4), that during a patient procedure "multi piece device with tension wire to create a rigid retractor when tension applies to internal wire.The wire failed and pieces of the device fell into the abdomen.The failure was witnessed through the laparoscope." user facility personnel were able to retrieve all pieces and the procedure was completed successfully.No report of injury.

• Brand Name: SNOWDEN-PENCER MIS DIAMOND-FLEX TRIANGULAR RETRACTOR
• Common Device Name: SNOWDEN-PENCER
• Manufacturer (Section D): CAREFUSION INC.; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION INC.; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 18461119
• Report Number: 1423507-2024-01000
• Device Sequence Number: 11541898
• Product Code: GCJ
• UDI-Device Identifier: 10885403122835
• UDI-Public: 10885403122835
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 01/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 89-6112
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 01/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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