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

Model Number	89-10044
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Failure to Power Up (1476); Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: a root cause could not be determined.No issues were identified during analysis of production records.An inspection of the defective sample could not be performed because a sample was not returned.If the defective sample is returned, the case will be reopened.Corrective action: a corrective action was not taken due to the root cause determination.Investigation summary: an internal complaint ((b)(4)) was received for a convenience kit (part 89-10044, lot 49860941) that contained an electrosurgical pencil that would not work.The end user reported this incident to the fda (report mw5088867).A defective sample initially was reported to be available for return.However, as of the date of this report, a sample has not been received for evaluation.The work order for the reported finished good lot number was reviewed for possible discrepancies that may have contributed to the event.No discrepancies were identified.The bill of materials for the finished good kit was reviewed and (b)(4) was identified as the electrosurgical pencil contained within the kit.This pencil is manufactured at deroyal (b)(4).The investigator at the (b)(4) facility reviewed the production records for the finished pencil and its sub-assembly.No discrepancies were identified.Product in-process at (b)(4) was inspected.Eighty units were inspected using a continuity test and all units were accepted.From 2017 to present, three complaints have been received for electrosurgical pencils exhibiting a similar issue.However, the part numbers associated with these complaints were different than the one currently under investigation.The investigation is complete at this time.If new and critical information is received, this report will be updated.
Event or Problem Description
The electrosurgical pencil that was packaged in a convenience kit would not work.After checking the machine to ensure it was working, a new pencil was opened and worked.

• Brand Name: C-SECTION PACK
• Common Device Name: DISPOSABLE SURGICAL INSTRUMENT KIT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 9122465
• Report Number: 3005011024-2019-00012
• Device Sequence Number: 2333337
• Product Code: KDD
• UDI-Device Identifier: 00749756980081
• UDI-Public: 00749756980081
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 09/25/2019

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: 89-10044
• Device Lot Number: 49860941
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1