MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER EDGE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E1455BNSB
Medical Device Problem Codes	Peeled/Delaminated (1454); Contamination /Decontamination Problem (2895); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during procedure, the insulation of the blade tip broke in pieces at the time of making an incision.Some pieces fell into the patient¿s cavity, but the pieces could not be located on either inside the patient¿s cavity and outside the cavity.It was noted that the caused of the issue was due to device had been on electron beam sterilization.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.Five unused devices were also received.The reported condition was confirmed.Inspection found the ptfe insulator was damaged and torn.The damage to the electrode indicates the user mishandled the electrodes.Engineering agreed with the investigation results.The customer indicated that the cause of the failure might be that the device was subjected to electron beam sterilization.Instructions for use (ifu) clearly warns the user not to clean or sterilize the device for reuse.The investigation identified the root cause of the reported event to be attributed to user handling damage.The ifu states: this product cannot be adequately cleaned and/or sterilized by the user in order to facilitate safe reusage, and is therefore intended for single use.Attempts to clean or sterilize these devices may result in a bio-incompatibility, infection or product failure risks to the patient.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EDGE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7839127
• Report Number: 1717344-2018-01153
• Device Sequence Number: 2434477
• Product Code: GEI
• UDI-Device Identifier: 10884521038479
• UDI-Public: 10884521038479
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: E1455BNSB
• Device Catalogue Number: E1455BNSB
• Device Lot Number: 71920181X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other