MAUDE Adverse Event Report: STERILMED, INC. SCISSORS INSERT METZENBAUM DISPOSABLE; ELECTROSURG, CUT/COAG ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED

Model Number	AESPO888
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product analysis lab received the device for evaluation.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that during pre-op for a procedure, the reprocessed scissors insert metzenbaum disposable packaging contaminated the device and became unsterile.The device never came in contact with the patient and there was no patient consequence or injury.
Additional Manufacturer Narrative
It was reported that during pre-op for a procedure, the reprocessed scissors insert metzenbaum disposable packaging contaminated the device and became unsterile.The package and device were received.The chevron side, sealed by the packaging oem, is the section that has been opened by the handler.The sterilmed sealed part of the package remains sealed and is not affected.It is observed that the original equipment manufacturer seal has been pulled apart in an irregular manner, starting at the left edge of the chevron, rather than the center.Excessive pull force has been applied to the left-side of the package's seal, shearing into the tyvek material.The pull extends 12 inches down the left side of the seal, compared to the right-side seal, pulled down only 11 inches, with no visible shearing observed.While there are no observed loose fragments, fibers or foreign matter on the returned device, opening a package incorrectly could compromise the sterility of the contents.The packaging was damaged upon its opening.Purchased packaging is inspected by the supplier, and a certificate of compliance is sent with each shipment.The device history record of lot 2130477 (manufacturing date 01/20/2021) was reviewed and the device and packaging passed all visual inspection criteria prior to distribution to the customer.A manufacturing record evaluation was conducted and there were no identified nonconformances.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: SCISSORS INSERT METZENBAUM DISPOSABLE
• Common Device Name: ELECTROSURG, CUT/COAG ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer (Section G): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12739135
• Report Number: 2134070-2021-00022
• Device Sequence Number: 11992040
• Product Code: NUJ
• UDI-Device Identifier: 10888551004954
• UDI-Public: 10888551004954
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K073613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2021

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: 01/20/2022
• Device Model Number: AESPO888
• Device Catalogue Number: AESPO888
• Device Lot Number: 2130477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown