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

Model Number	PPI0280
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
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 not retained and no pictures or videos were provided.Attempts to recreate the failure using retained devices were unsuccessful under normal and extreme use cases.However, the collar was able to be dislodge only by readvancing the pushrod after retraction and closure of the specimen bag (country to the ifu steps), which also required the internal ratcheting system to be overridden.Based on the currently available information, the most likely root cause is user error.Specifically, the user overrode the ratcheting mechanism and readvanced the pushrod at least partially, either on accident or on purpose.This action would cause the collar to dislodge from the introducer tube.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.
Event or Problem Description
On (b)(6) 2026 at 1545 during robotic chest exploration, hematoma evacuation surgery, there was a clear cylindrical object noted in the chest cavity.The surgeon removed the object and it was identified as a clear string guide from the pmi solobag, item ppi0280, lot 2501020.Six bags were used during procedure, with all 12 string guides located and counted.Risk manager met with or manager, first assist, and rn to review event, and noted the following: this is a "new"/different product than the previous specimen retrieval system that was used.The string guide (looks like a clear dull yellow bead about 1/4 inch in size) was dislodged from the deployment section of the device.When the string was cut to retrieve the specimen from the specimen bag, the bead, which generally stays in the deployment section (a "stop" for the bag deployment), was on the string and fell off the string and into surgical site.

• Brand Name: PMI SOLOBAG
• Common Device Name: SPECIMEN RETRIEVAL BAG
• Manufacturer (Section D): DANNIK, LLC; 941 w. morse blvd.; suite 100; winter park
• 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 32789
• MDR Report Key: 24421919
• Report Number: 3015775837-2026-00001
• Device Sequence Number: 10577296
• Product Code: GCJ
• UDI-Device Identifier: 00850013527793
• UDI-Public: (01)00850013527793
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K250411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• 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: PPI0280
• Device Lot Number: 2501020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2025
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: White