MAUDE Adverse Event Report: CAREFUSION, INC DIAMOND-VIEW RETRACTORSYSTEM 6IN; RETRACTOR, FIBEROPTIC

Catalog Number 88-1001

Device Problem Power Problem (3010)

Patient Problem Burn(s) (1757)

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

Initial emdr pr # 1470764.If any additional information or a sample is received a follow up emdr will be submitted.Date of event was unknown.Bd awareness date was used instead.Site: manufacturing site was unknown as no product details were provided by the customer.(b)(4) office was used as a placeholder.

Event Description

Patient was undergoing a breast implant expander surgery/breast reconstruction, left and right with revision of axillary scar.The surgeon used a fiber optic retractor with a fiber optic light system.The fiber optic cable connector (which attached the retractor to the power source) heated up and transmitted heat to the patient resulting a burn.

Manufacturer Narrative

Supplemental emdr for (b)(6).If any additional information or a sample is received a follow up emdr will be submitted.Date of event was unknown.Bd awareness date was used instead.Site: manufacturing site was unknown as no product details were provided by the customer.Bd vernon hills office was used as a placeholder.Medical device brand name - device was not returned so the reported device the cable was used with was reported.Medical device catalog # - device was not returned so the reported device the cable was used with was reported.Investigation results: a physical sample was not available for investigation but the customer was able to provide photos of the device and cable.Unfortunately, the photos did not show the product details for the cable and the photos revealed evidence that the cable may not have been a certified v.Mueller/snowden pencer device.The v.Mueller manufactured cables for this retractor have a different plug end than the one seen in the photo.The v.Mueller cables have a ribbed region near the plug and the cables observed in the photos showed a smoother region.The customer has been informed of this difference.A definitive root cause could not be determined from the provided photos.Based off of previous investigations and the ifu for this device the root cause was most likely user error.The cable/cable connector for this device generates heat during use and should not be placed on the patient/patient drapes.H3 other text : evaluation has been performed.

Event Description

Patient was undergoing a breast implant expander surgery/breast reconstruction, left and right with revision of axillary scar.The surgeon used a fiber optic retractor with a fiber optic light system.The fiber optic cable connector (which attached the retractor to the power source) heated up and transmitted heat to the patient resulting a burn.

• Brand Name: DIAMOND-VIEW RETRACTORSYSTEM 6IN
• Type of Device: RETRACTOR, FIBEROPTIC
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• MDR Report Key: 9813279
• MDR Text Key: 201745805
• Report Number: 1423507-2020-00012
• Device Sequence Number: 1
• Product Code: FDG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 88-1001
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR