MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C2A12, GELPOINT V-PATH PLATFORM, 9.5CM; CULDOSCOPE (AND ACCESSORIES)

Model Number	C2A12
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon the completion of investigation.
Event or Problem Description
Name of procedure being performed: vnotes hysterectomy.Description transcribed from telephone call with applied medical representative 23nov20: polyurethane sheath has partially separated from the placement ring during vnotes procedure.The damaged alexis was removed, and a new product was opened - the procedure was completed using the alexis from the second package but the original gelport was used.No consequences or injury for patient.The tear occurred from bottom of sheath at the ring, the tear was approximately 2 inches in diameter.The product is in theatres 2 in quarantine.Patient status: no consequences or injury to the patient.Type of intervention: change of device: alexis component.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that the sheath had separated from the inner ring at the seal line.The inner ring of the event unit was also unflipped.Based on the condition of the returned unit, it is likely the reported event occurred when the event unit was pulled with a large force, which caused the inner ring to unflip and the sheath to separate from the inner ring.This event is not reportable as it is unlikely to cause or contribute to death or serious injury.This report is a follow-up report for medwatch # 01681.
Event or Problem Description
Name of procedure being performed: vnotes hysterectomy.Description transcribed from telephone call with applied medical representative 23nov20: polyurethane sheath has partially separated from the placement ring during vnotes procedure.The damaged alexis was removed, and a new product was opened - the procedure was completed using the alexis from the second package but the original gelport was used.No consequences or injury for patient.The tear occurred from bottom of sheath at the ring, the tear was approximately 2 inches in diameter.The product is in theatres 2 in quarantine.Patient status: no consequences or injury to the patient.Type of intervention: change of device - alexis component.

• Brand Name: C2A12, GELPOINT V-PATH PLATFORM, 9.5CM
• Common Device Name: CULDOSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 11009011
• Report Number: 2027111-2020-00643
• Device Sequence Number: 19974274
• Product Code: HEW
• UDI-Device Identifier: 00607915138660
• UDI-Public: (01)00607915138660(17)221114(30)01(10)1375255
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K191294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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 Expiration Date: 11/14/2022
• Device Model Number: C2A12
• Device Catalogue Number: 101472317
• Device Lot Number: 1375255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GRASPERS.; SUTURES.; VOYANT HANDPIECE.