MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. REUSE LAP ELEC SHAFT FOOT 32CM; REUSABLE LAP ELECTRODE SHAFT FOOT 32CM

Catalog Number	0690S
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of event is unknown.Batch # unknown.Additional information received: plastic coating (black insulation) came completely off but did not fall into the patient.Investigation summary: 1 each 0690s unknown lot number was returned for evaluation.During visual inspection damage was observed, cuts/indents all along the black insulation.Also observed the insulation has damaged areas at the proximal end were the insulation has been scraped and insulation is fraying.This damage is consistent with the devices coming in contact with other instrumentation.The complaint is confirmed.The lot was not provided; therefore, the manufacturing records could not be reviewed.
Event or Problem Description
It was reported that during an unknown procedure, after cleaning the device the plastic coating came off.No patient involvement.

• Brand Name: REUSE LAP ELEC SHAFT FOOT 32CM
• Common Device Name: REUSABLE LAP ELECTRODE SHAFT FOOT 32CM
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 9221827
• Report Number: 1721194-2019-00126
• Device Sequence Number: 13565067
• Product Code: GEI
• UDI-Device Identifier: 10614559101247
• UDI-Public: 10614559101247
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K943055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/27/2019

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 Catalogue Number: 0690S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1