MAUDE Adverse Event Report: STERILMED, INC.; CLIP, IMPLANTABLE, REPROCESSED

Model Number	ETHMCL20
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with recent history of pigmented irregularly shaped nodular skin lesion.Undergoing wide excision melanoma, left shoulder with sentinel node biaxial, full thickness skin graft.The ethicon ligaclip mca (reprocessed) had debris in packaging.Observation was made prior to opening packaging, not used on patient.

• Brand Name: NA
• Common Device Name: CLIP, IMPLANTABLE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway n suite 2; plymouth MN 55446
• MDR Report Key: 9976895
• Report Number: 9976895
• Device Sequence Number: 11553178
• Product Code: NMJ
• UDI-Device Identifier: 10888551019057
• UDI-Public: (01)10888551019057
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/10/2020
• Report Date (Section F): 04/10/2020

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 Model Number: ETHMCL20
• Device Catalogue Number: ETHMCL20
• Device Lot Number: 2108693
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Weight: 80
• Date Report Sent to FDA: 04/10/2020