MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. 10FT SMOKE PENCIL UCONN; RETURN ELECTRODE CABLE, DUAL PLATE

Catalog Number	251010J
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 11/2/2023.B3: exact date is unk.Assumed first day of the month.Investigation summary.The product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the 251010j device was returned sealed inside its original packaging.Upon visual inspection, it was observed that the packaging was damaged; it was observed to have a tear in the area of the seal that created a hole in the package.Due to the damages found on the packaging, a possible cause for these conditions is due to improper handling during transit or storage all ees product is 100% inspected prior to release.The information you provided is compiled monitored and reviewed on a routine basis for any associated trends.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot: 2208230, and no non-conformances were identified.Additional information was requested, and the following was obtained: according to the additional information it stated, ¿sterility of some of the pencils is affected by this damaged box¿.We need to know the exact number of pencils that the sterility was affected.I did not open the box - it was sent back to wqc - but i don¿t believe all 20 pencils were involved.But the customer wanted the entire box replaced because of the damaged corner and you could see that there were impacted pencils by looking through the hole in the box.I saw the damaged box.One side of the box was ripped at the side.Sterility of some of the pencils is affected by this damaged box.
Event or Problem Description
It was reported that when the loading dock received their order last week they received one damaged box of smoke evacuation pencils.Customer stated that they would have kept them but the product packaging is also damaged.There were no adverse consequences reported.

• Brand Name: 10FT SMOKE PENCIL UCONN
• Common Device Name: RETURN ELECTRODE CABLE, DUAL PLATE
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 18054953
• Report Number: 1721194-2023-00125
• Device Sequence Number: 15172886
• Product Code: GEI
• UDI-Device Identifier: 10614559105573
• UDI-Public: 10614559105573
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K982130
• 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
• Report Date (Section B): 11/02/2023

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: 02/28/2026
• Device Catalogue Number: 251010J
• Device Lot Number: 2208230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• 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