MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL, S.R.L. FLEXIBLE LIGHT HANDLE COVERS; LIGHT, SURGICAL, ACCESSORIES

Model Number 26-012

Device Problems Component Falling (1105); Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an internal complaint ((b)(4)) was received indicating a flexible light handle cover fell off a light during a procedure, compromising the sterile field.A defective sample was not available for return.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.

Event Description

The flexible light handle covers (part number 26-012) are falling off the lights during procedures and compromising the sterile field.

Event Description

The flexible light handle covers (part number 26-012) are falling off the lights during procedures and compromising the sterile field.

Manufacturer Narrative

Root cause: the raw material cover is supplied to deroyal by (b)(4).Therefore, a supplier corrective action request (scar) was issued to (b)(4).In its response, (b)(4) stated detection of the defect is not possible due to the extremely low frequency ((b)(4)).A potential root cause could be the sterilization process that occurs after (b)(4) manufacturing or handling of the cover during application in the operating room.Corrective action: in its response, (b)(4) stated it will continue to follow procedures outlined for inspection frequency of the product fit and monitor product during production utilizing inspection plan and go/no go gauges that are required for the product.(b)(4) also suggested evaluation of the sterilization process.Deroyal has found no evidence this issue is the result of sterilization as the reported defects have been occurring in sterile and non-sterile light handle covers.Investigation summary: an internal complaint ((b)(4)) was received indicating a flexible light handle cover fell off a light during a procedure, compromising the sterile field.A defective sample was not available for return.The customer provided photos; however, these photos do not show the defective light handle cover.The device history record was reviewed for discrepancies that may have contributed to the reported defect.No discrepancies were identified.A scar was issued to (b)(4), the raw material manufacturer, and a response has been received.Preventive action: a preventive action has not been taken.The investigation is complete at this time.If new and critical information is received, this report will be updated.

• Brand Name: FLEXIBLE LIGHT HANDLE COVERS
• Type of Device: LIGHT, SURGICAL, ACCESSORIES
• Manufacturer (Section D): DEROYAL INTERCONTINENTAL, S.R.L.; km 7 autopista joaquin balague; pisano free zone building 49; santiago, santiago ; DR
• MDR Report Key: 7118553
• MDR Text Key: 95798334
• Report Number: 3004605321-2017-00006
• Device Sequence Number: 1
• Product Code: FTA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26-012
• Device Lot Number: 44992742
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1