MAUDE Adverse Event Report: BRENTWOOD INDUSTRIES FLEXIBLE LIGHT HANDLE COVER; LIGHT, SURGICAL, ACCESSORIES

Model Number 26-012

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an internal complaint ((b)(4)) was received indicating a light handle cover (part 26-012) fell from the light handle during surgery and landed in the surgical field.The customer initially reported a sample to be available for evaluation.As of the date of this report, a sample has not been returned.The light handle cover is contract manufactured by (b)(4).Therefore, a supplier corrective action request was issued was issued to (b)(4) on march 21, 2017.A response is due may 1, 2017.The investigation is incomplete at this time.When new and critical information is received, this report will be updated.

Event Description

The light handle cover fell off from the handle and landed in the surgical field.

Manufacturer Narrative

Root cause: the raw material part is supplied to deroyal by (b)(4).Therefore, a supplier corrective action request was issued to (b)(4).In its response, (b)(4) identified a possible root cause of the handle in the field being defective.Corrective action: in its scar response, (b)(4) stated it will continue to follow its procedures regarding inspection frequency for product fit.It will continue to monitor product during production utilizing inspection plan and go/no-go gauges that are required for product.Additionally, (b)(4) requested deroyal to supply (b)(4) with another handle to compare against the handle (b)(4) is using in process.(b)(4) has also requested deroyal to investigate the possibility of a design change.Investigation summary: an internal complaint (call 40131) was received indicating a light handle cover (part 26-012) fell from the light handle during surgery and landed in the surgical field.The customer initially reported a sample to be available for evaluation.Samples were returned for evaluation.The work order was reviewed for possible discrepancies that may have contributed to the reported event.No discrepancies were identified.The light handle cover is contract manufactured by (b)(4) industries, inc.Therefore, a supplier corrective action request (scar) was issued was issued to (b)(4)on march 21, 2017.The available samples also were forwarded to (b)(4).A scar response was received may 23, 2017.The response was reviewed and accepted by deroyal personnel on june 12, 2017.The 2014-2016 scar and supplier notification letter logs were reviewed for similar complaints.Similar complaints for the item were identified.Deroyal will continue to monitor post-market feedback.Preventive action: a preventive action has not been taken.The investigation is complete at this time.When new and critical information is received, this report will be updated.

Event Description

The light handle cover fell off from the handle and landed in the surgical field.

• Brand Name: FLEXIBLE LIGHT HANDLE COVER
• Type of Device: LIGHT, SURGICAL, ACCESSORIES
• Manufacturer (Section D): BRENTWOOD INDUSTRIES; 621 brentwood dr; reading PA 19611
• Manufacturer (Section G): DEROYAL INTERCONTINENTAL, S.R.L.; km 7, autopista joaquin balagu; pisano free zone, building 49; santiago, santiago ; DR
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 6440281
• MDR Text Key: 71324608
• Report Number: 3004605321-2017-00001
• Device Sequence Number: 1
• Product Code: FTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 26-012
• Device Lot Number: 43702088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1