MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. UNIVERSAL SMOKE EVACUATION ATTACHMENT, SNAP-ON SHEATH; ELECTROCAUTERY SHROUD

Catalog Number 88-000600

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/31/2016

Event Type  malfunction  

Manufacturer Narrative

Root cause: as of the date of this report, a defective sample is unavailable.With no sample available for a physical analysis and no discrepancies identified in the work order, a root cause cannot be determined.Corrective action: no corrective action will be taken at this time.Investigation summary: an internal complaint (call 36579) was received reporting that the plastic handpiece of a universal smoke evacuator attachment device (finished good 88-000600) had broken off inside a patient.The customer indicated the device was available for return, and deroyal issued the customer a ups call tag on april 5.However, as of the date of this report, the ups call tag has not been utilized and the sample has not be returned to deroyal for evaluation.The device history record was reviewed for the reported lot number (31493178).No rejects or discrepancies were identified during the manufacturing of the device.Corrective and preventive action (capa) and material release report (mrr) logs for a period of two years were reviewed with no non-conformities identified that were related to the reported issue.The risk analysis documentation was reviewed.No failure modes related to the reported issue were identified.A revision, therefore, is needed.Preventive action: no preventive action will be taken at this time.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

A piece of the plastic hand piece broke off during surgery and went inside of the patient.The item was retrieved from the patient.No additional treatment was required.

• Brand Name: UNIVERSAL SMOKE EVACUATION ATTACHMENT, SNAP-ON SHEATH
• Type of Device: ELECTROCAUTERY SHROUD
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.; global park, box 180-3006, 602; parkway, la aurora; heredia, heredia 146 ; CS 146
• Manufacturer (Section G): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.; global park, box 180-3006, 602; parkway, la aurora; heredia, heredia 146 ; CS 146
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 5610886
• MDR Text Key: 43786256
• Report Number: 9613793-2016-00003
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 88-000600
• Device Lot Number: 31493178
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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