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

Model Number	PNI0750
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
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.Unfortunately the end user has been unable to provide any additional information.No pictures or videos of the suspect product were provided.Although it was indicated that the device was available for return and a return label was provided to the end user, the device has not been returned today and the tracking show no movement at this time.Without additional information, the exact root cause cannot be determined given the available information.However, dannik has reviewed our prior investigations related to what we believe to be similar events and it is believed that the most likely root cause is user error.Specifically, that the bag was in contact with a sharp object or instrument, such as a grasper or ligation clip.Additionally it is unknown if the user enlarged the port site during extraction, as failure to properly enlarge the port site during extraction would have placed high pressure on this area and contributing to the bag rupture.Dannik has provided these findings to our customer to share with the end user.No patient harm was been reported in this event or in any similar events reviewed as part of this investigation.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.
Event or Problem Description
Endoscopic basket broken -------------------------------------- what was the original intended procedure? : 1.Flexible bronchoscopy 2.Left video-assisted thoracoscopy with left lower lobectomy [cpt 32663] 3.Mediastinal and regional lymph node dissection [cpt +32674] 4.Multilevel intercostal nerve blocks.-------------------------------------- what problem did the user have: device malfunction - that is, the device did not do what it was supposed to do;.
Additional Manufacturer Narrative
Suspect product was returned after our intial report.This report serves as a follow-up based on the inspection of the suspect device.The device was returned with the bag not on the arms and the tether still through the introducer but detached from the pull loop.Everything else was intact.The bag didn't have any holes or tears and didn't appear to have been retracted into the tube at all (i.E.There was no wrinkling or creasing on the bag that usually appears after pulling it into the tube).There was also no blood on the bag or other indications that the device had contacted the patient in any capacity.The device was reassembled (bag placed back onto the arms, tether re-attached to the pull loop, etc.).Everything functioned normally.Unfortunately, the contacts at the user facility have still been unable to provide any additional information on the incident.However, based on the review of the returned device, the most likely root cause is that the operator detached tether prior to retracting the bag during initial setup.Dannik has provided these findings to our customer to share with the end user.No patient harm was been reported in this event or in any similar events reviewed as part of this investigation.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 reopen 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: 22979600
• Report Number: 3015775837-2025-00003
• Device Sequence Number: 15687863
• 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,Followup
• Report Date (Section B): 09/05/2025

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: CEGPNI075003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/02/2025
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Race: White