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

Model Number	C2A15
Medical Device Problem Codes	Use of Device Problem (1670); Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation and no lot number has been provided to applied medical.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: salpingectomy.Event description: during this salpingectomy case, upon starting the laparoscopic portion, the surgeon noticed the view of the pelvis was not what was expected as the fallopian tubes were not in view and the alexis inner ring seemed to be off-center.The alexis was removed and replaced, using the introducer and rolling the inner ring down three times, but the same view remained.It was discovered that the patient had a small uterus, and the inner ring was placed deep into the abdomen past the uterus and the fallopian tubes.The alexis was replaced again, using the introducer and rolling the inner ring down twice, but the same view remained, and the uterus and adnexa were caught behind the alexis sheath.The surgeon used a laparoscopic grasper to pull back the alexis sheath by grabbing the anterior inner ring and pulling it closer so that the inner ring sat closer to the cervix.The inner ring was not difficult to manipulate, and the uterus and adnexa fell out of the space they were trapped in easily.The surgeon did not perform a tissue sweep on the first insertion, but did perform a tissue sweep on subsequent attempts.The surgeon noted that they could feel that the ring was fully in the posterior colpotomy, but that they weren't sure exactly where the ring was seated as they weren't sure if they were feeling the posterior uterus when sweeping the anterior opening.The surgeon did not unroll the alexis outer ring prior to attempting to free the uterus and fallopian tubes.Once the view of the uterus and adnexa were gained, the case proceeded normally.The case was successfully completed via vnotes and there was no patient injury as a result of tissue entrapment.Additional information provided by [name] on 04feb2025.Lot number was not collected.No apparent adverse outcome.Intervention: the surgeon used a laparoscopic grasper to pull back the alexis sheath.The inner ring was not difficult to manipulate, and the uterus and adnexa fell out of the space they were trapped in easily.Patient status: no apparent adverse outcome.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, the customer¿s experience of tissue entrapment was confirmed based on the event description.Based on the description of the event, it is possible that a finger tissue sweep was not sufficient to discern that tissue was entrapped.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Correction: h6.Updated device code.
Event or Problem Description
Procedure performed: salpingectomy event description: during this salpingectomy case, upon starting the laparoscopic portion, the surgeon noticed the view of the pelvis was not what was expected as the fallopian tubes were not in view and the alexis inner ring seemed to be off-center.The alexis was removed and replaced, using the introducer and rolling the inner ring down three times, but the same view remained.It was discovered that the patient had a small uterus, and the inner ring was placed deep into the abdomen past the uterus and the fallopian tubes.The alexis was replaced again, using the introducer and rolling the inner ring down twice, but the same view remained, and the uterus and adnexa were caught behind the alexis sheath.The surgeon used a laparoscopic grasper to pull back the alexis sheath by grabbing the anterior inner ring and pulling it closer so that the inner ring sat closer to the cervix.The inner ring was not difficult to manipulate, and the uterus and adnexa fell out of the space they were trapped in easily.The surgeon did not perform a tissue sweep on the first insertion, but did perform a tissue sweep on subsequent attempts.The surgeon noted that they could feel that the ring was fully in the posterior colpotomy, but that they weren't sure exactly where the ring was seated as they weren't sure if they were feeling the posterior uterus when sweeping the anterior opening.The surgeon did not unroll the alexis outer ring prior to attempting to free the uterus and fallopian tubes.Once the view of the uterus and adnexa were gained, the case proceeded normally.The case was successfully completed via vnotes and there was no patient injury as a result of tissue entrapment.Additional information provided by [name] on 04feb2025 lot number was not collected.No apparent adverse outcome.Intervention: the surgeon used a laparoscopic grasper to pull back the alexis sheath.The inner ring was not difficult to manipulate, and the uterus and adnexa fell out of the space they were trapped in easily.Patient status: no apparent adverse outcome.

• 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: 21318521
• Report Number: 2027111-2025-00343
• Device Sequence Number: 12912485
• Product Code: HEW
• UDI-Device Identifier: 00607915138493
• UDI-Public: (01)00607915138493
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/15/2025

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: C2A15
• Was Device Available for Evaluation?: No
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LAPAROSCOPIC GRASPER.
• Patient Sex: Unknown