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

Model Number	89-9429
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Sparking (2595)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint ((b)(4)) was received indicating a hand cautery pencil included within a convenience kit (part 89-9429, lot 5110378) was sparking during use.A sample was not available for evaluation.The work order for the reported finished good lot was reviewed for any discrepancies that may have contributed to the reported event.No discrepancies were identified.The bill of materials for the convenience kit was reviewed and the affected component was identified as raw material (b)(4).This is a cautery pencil supplied to deroyal by conmed.A supplier corrective action request (scar) was issued to conmed.As of the date of this report, a response has not been received.The investigation is ongoing.When new and critical information becomes available, this report will be updated.
Event or Problem Description
The hand cautery in a convenience kit sparked during use.
Event or Problem Description
The hand cautery in a convenience kit sparked during use.
Additional Manufacturer Narrative
Root cause: the cautery pencil contained in the convenience kit is supplied to deroyal by conmed.Therefore, a supplier corrective action report (scar) was issued to conmed.In its response, conmed stated it was unable to identify a root cause for the reported issue because a sample was not available for evaluation.Corrective action: a new electrical test was implemented (b)(6) 2019 as part of an improvement.The reported lot number for the cautery pencil was prior to the implementation of this improved electrical test.Investigation summary: an internal complaint (b)(4) was received indicating a hand cautery pencil included within a convenience kit (part 89-9429, lot 5110378) was sparking during use.A sample was not available for evaluation.The work order for the reported finished good lot was reviewed for any discrepancies that may have contributed to the reported event.No discrepancies were identified.The bill of materials for the convenience kit was reviewed and the affected component was identified as raw material 709124.This is a cautery pencil supplied to deroyal by conmed.A supplier corrective action request (scar) was issued to conmed.A response was received and accepted april 13, 2020 by deroyal personnel.The investigation is complete.If new and critical information becomes available, this report will be updated.

• Brand Name: EMERGENCY C-SECTION BASIN
• Common Device Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette, tn
• MDR Report Key: 9818146
• Report Number: 3005011024-2020-00002
• Device Sequence Number: 1568287
• Product Code: KDD
• UDI-Device Identifier: 00749756909075
• UDI-Public: 00749756909075
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 89-9429
• Device Lot Number: 51100378
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1