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

Model Number	PNI2000
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/01/2025
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 and the device was not available for return.Without additional information, the exact root cause cannot be determined given the available information.Given this information and no response on follow-up for clarification, it is believed that the most likely root cause for the user's experience is that the user failed to follow the proper operating steps as detailed in the instructions for use.Specifically, the user pulled the closure suture prior to removing or fully removing the biasing arms.Specifically, the report states "the bare metal tips were identified by clinical staff to be jutting out awkwardly before the bag was completely cinched".Dannik has provided these findings to our customer to share with the end user.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.
Event or Problem Description
Describe the event or problem: during procedure, a 15 mm endocatch bag was used for the extraction of the patient's uterus via the vagina.During the procedure, the bag did not fully deploy when initially utilized.This was then followed by the metal rim releasing in the peritoneal cavity; the bare metal tips were identified by clinical staff to be jutting out awkwardly before the bag was completely cinched.As the endocatch bag was being removed vaginally, the jutting bare metal tips caused trauma along the vaginal canal creating a laceration of the tissue.Staff noted that the vaginal laceration was not significant but the patient was taken back to the pacu [post anesthesia care unit] after the bleeding increased in recovery and had to go back under anesthesia for suturing of the laceration.What was the original intended procedure? the intended procedure was for the 15mm endocatch bag to be fully deployed when initally utilized and with the metal tips being encapsulated by the proprietary rip-stop nylon bag.What problem did the user have: device malfunction: that is, the device did not do what it was supposed to do.Therapies being used on the patient at the time of the event that may have caused or contributed to the event: not applicable.

• 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: 23658000
• Report Number: 3015775837-2025-00004
• Device Sequence Number: 10055075
• Product Code: GCJ
• UDI-Device Identifier: 00850013527649
• UDI-Public: (01)00850013527649
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PNI2000
• Device Lot Number: CFBPNI200001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2025
• 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; Required Intervention
• Patient Sex: Unknown