MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROBE SAPHYRE II 60DEG 3MM SUCTION; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	7210113
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the insulation coating of the shaft was peeled off during use.All peeled parts were removed from the patient.The procedure was successfully completed with the same wand.No delay and no patient injury were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h3, h6: the device, which was used in a procedure, was returned for evaluation.The evaluation was performed by smith and nephew and could confirm the customer complaint for the coating on the shaft peeled off.A visual inspection was performed and showed severe insulation damage.This damage is caused by contact with another source and confirmed not originate from manufacturing, packaging, or labeling defects.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found no related failures.No manufacturing related defects were observed.No further investigation is required.

• Brand Name: PROBE SAPHYRE II 60DEG 3MM SUCTION
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 9617035
• Report Number: 3003604053-2020-00004
• Device Sequence Number: 523898
• Product Code: GEI
• UDI-Device Identifier: 03596010483287
• UDI-Public: 03596010483287
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K991218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2020

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 Expiration Date: 04/09/2022
• Device Model Number: 7210113
• Device Catalogue Number: 7210113
• Device Lot Number: 2030443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1