MAUDE Adverse Event Report: DANNIK, LLC PMI SUPERBAG; SPECIMEN RETRIEVAL BAG

Model Number	PNI0750
Medical Device Problem Codes	Use of Device Problem (1670); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Describe the event or problem: device malfunction.The bag didn't deploy properly and we could not put a specimen inside it.Another bag was used and it worked as expected.Device is available for return.What was the original intended procedure? robotic vats procedure.What problem did the user have: device malfunction - that is, the device did not do what it was supposed to do.
Additional Manufacturer Narrative
Dannik has completed a thorough review of all available records related to this device and associated lot number including manufacturing and incoming inspection records for all subassemblies, components, and raw materials.This lot passed all manufacturing and quality control inspections, and no irregularities or abnormalities were found during the record review.Review of vigilance reports did not reveal any trends to a specific lot, and this is the first known occurance of this issue to date.The suspect device was returned and inspected.The returned device was found to be in good working order and fully functional, but had the bag and push rod rotated in relation to the introducer tube.Howvere, the embossed "top" indicators on the pull loop were still properly aligned with the bag mouth opening as designed and indicated in the intructions for use.Therefore the most likely root cause is that the user depolayed the bag upside down and could not locate the bnag opening.Dannik has provided these findings to our customer to share with the end user.No patient harm was been reported in this event, nor is any injuiry likely to occure.Dannik will continue to monitor this issue through our vigilance system for trends and take appropriate actions as necessary to ensure the continued performance and safety of the product.If additional information regarding this incident is obtained which was not known or not available prior to this report, dannik will re-open and reassess our investigation and response at that time.We have determined that this event is not reportable as defined by 21 cfr 803 as the identified malfunctions are not likely to cause or contribute to a death or serious injury.However, this report is being submitted as an official response to the medsun report as required by our internal procedures.

• Brand Name: PMI SUPERBAG
• Common Device Name: SPECIMEN RETRIEVAL BAG
• Manufacturer (Section D): DANNIK, LLC; 941 w. morse blvd.; suite 100; winter park FL 32789
• Manufacturer (Section G): DANNIK, LLC; 3201 e. colonial dr.; suite m3; orlando FL 32803
• Manufacturer Contact: daniel doerr ; 941 w. morse blvd.; suite 100; winter park, FL 32789 ; 3217501155
• MDR Report Key: 23659320
• Report Number: 3015775837-2025-00005
• Device Sequence Number: 10055145
• Product Code: GCJ
• UDI-Device Identifier: 00850013527625
• UDI-Public: (01)00850013527625
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K200053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

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: PNI0750
• Device Lot Number: CEIPNI075001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2024
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: White