MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES GELPOINT V-PATH; CULDOSCOPE (AND ACCESSORIES)

Model Number	C2A12
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Name of procedure being performed: vnotes hysterectomy.Detailed description of event: hospital: [facility], model #: c2a12, lot #: 1527639.The medical device was opened during surgery.The nurse noticed a hole in the packaging after the device was opened and before it was about to be used on the patient.The device was not used, and the procedure switched to laparoscopic due to the patient's anatomy.The product and its packaging will return to amr.The account manager will provide a picture of the packaging.Additional information provided by [name] on 05dec2024 via email: to specify.The circulator nurse opened the outer peel pack as the scrub tech reached in to remove the plastic packaging that contained all the components.At that point the circulator was checking the packaging she peeled open and found a hole in that peel pack, and then directed the scrub tech not to open the remaining plastic packaging and to hand it off.My reason for bringing this up is that there is no reason to sterilize the product before returning to rsm.It was never removed from the inner plastic container packaging.So, they will be returning the unopened plastic packaging, the damaged peel pack packaging, and it will be in the original product box.Type of intervention: changed to laparoscopic procedure due to patient's anatomy.Patient status: no patient injury indicated.
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: vnotes hysterectomy.Detailed description of event: hospital: [facility].Model #: c2a12.Lot #: 1527639.The medical device was opened during surgery.The nurse noticed a hole in the packaging after the device was opened and before it was about to be used on the patient.The device was not used, and the procedure switched to laparoscopic due to the patient's anatomy.The product and its packaging will return to amr.The account manager will provide a picture of the packaging.Additional information provided by [name] on 05dec2024 via email: to specify.The circulator nurse opened the outer peel pack as the scrub tech reached in to remove the plastic packaging that contained all the components.At that point the circulator was checking the packaging she peeled open and found a hole in that peel pack, and then directed the scrub tech not to open the remaining plastic packaging and to hand it off.My reason for bringing this up is that there is no reason to sterilize the product before returning to rsm.It was never removed from the inner plastic container packaging.So they will be returning the unopened plastic packaging, the damaged peel pack packaging, and it will be in the original product box.Type of intervention: changed to laparoscopic procedure due to patient's anatomy.Patient status: no patient injury indicated.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a hole in the packaging.Based on the condition of the returned unit, it is possible that the hole in the packaging was caused by improper handling of the unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.

• Brand Name: GELPOINT V-PATH
• Common Device Name: CULDOSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 20906848
• Report Number: 2027111-2024-00951
• Device Sequence Number: 13050413
• Product Code: HEW
• UDI-Device Identifier: 00607915138660
• UDI-Public: (01)00607915138660
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K191294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2025

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: C2A12
• Device Catalogue Number: 101474657
• Device Lot Number: 1527639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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
• Patient Sex: Unknown