MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. C-SECTION TRACEPACK; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Model Number	89-9338
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Arcing (2583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint (call (b)(4)) was received for a custom procedure pack (finished good 89-9338, lot 48053224) that contained a cautery pencil that arced during use.A sample was returned november 2, 2018 to deroyal.Due to the nature of the complaint, the samples could not be tested at deroyal's lafollette facility to validate the end user's report.The samples were forwarded november 5, 2018 to the pencil manufacturer.The complaint investigator reviewed the work order for possible discrepancies that may have contributed to the reported issue.No discrepancies were identified.The bill of materials was reviewed for the finished kit and the affected component was identified as raw material (b)(4) (lot 80860193x).This raw material is supplied to deroyal by covidien.The supplier corrective action requests (scar) and supplier notification letter logs were reviewed for similar complaints for the time period of 2016 to present.Similar incidents were found, and a scar and the returned samples were sent to covidien.As of the date of this report, a response has not been received.Deroyal will continue to monitor post-market feedback and will recognize in the future if the issue reoccurs.The investigation is incomplete at this time.When new and critical information is received, this report will be updated.
Event or Problem Description
A convenience kit contained a cautery pencil that arced during use.It was connected to a bovie generator.No injury was reported.
Event or Problem Description
A convenience kit contained a cautery pencil that arced during use.It was connected to a bovie generator.No injury was reported.
Additional Manufacturer Narrative
Root cause: the pencil contained within the deroyal convenience kit is supplied by covidien.Therefore, a supplier corrective action request (scar) was issued to covidien.In its response, covidien stated that the returned samples were evaluated and found to function normally and within product specification.Corrective action: in its scar response, covidien stated it did not take any corrective actions.Investigation summary an internal complaint ((b)(4)) was received for a custom procedure pack (finished good 89-9338, lot 48053224) that contained a cautery pencil that arced during use.A sample was returned november 2, 2018 to deroyal.Due to the nature of the complaint, the samples could not be tested at deroyal's lafollette facility to validate the end user's report.The samples were forwarded november 5, 2018 to the pencil manufacturer.The complaint investigator reviewed the work order for possible discrepancies that may have contributed to the reported issue.No discrepancies were identified.The bill of materials was reviewed for the finished kit and the affected component was identified as raw material 5-18677 (lot 80860193x).This raw material is supplied to deroyal by covidien.The supplier corrective action requests (scar) and supplier notification letter logs were reviewed for similar complaints for the time period of 2016 to present.Similar incidents were found, and a scar and the returned samples were sent to covidien.A response was received and accepted by deroyal on january 30, 2019.In its response, covidien stated the returned product was visually inspected and found to have no defects.No evidence of excessive heating was found on the returned samples.The associated electrodes were not returned for evaluation.The returned samples were plugged into a generator and activated with satisfactory results.Covidien's investigation found the device to function normally and within product specification.Deroyal will continue to monitor post-market feedback and will recognize in the future if the issue reoccurs.The investigation is complete at this time.If new and critical information is received, this report will be updated.

• Brand Name: C-SECTION TRACEPACK
• Common Device Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 8063734
• Report Number: 3005011024-2018-00008
• Device Sequence Number: 2190677
• Product Code: KDD
• UDI-Device Identifier: 00749756927864
• UDI-Public: 00749756927864
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 89-9338
• Device Lot Number: 48053224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1