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

Model Number C2A12

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

Name of procedure performed: vaginally assisted notes hysterectomy.Description of event: bleeding was reported after placement of the alexis ring, before the gelseal cap was attached.This obscured the field of vision, shortly after which the surgical team proceeded to remove the gelpoint v-path, ligate the uterine vessels, and then reattach the gelpoint v-path and continue with the procedure.The alexis ring was placed using the doyen retractor and the surgeon's fingers.The patient was (b)(6) of age, with poor tissue elasticity, and the surgeon thought perhaps this could have impacted the placement of alexis and caused the uterine vessels to tear.No changes in health, just bleeding as described above, which was addressed and then the procedure continued as planned.Intervention: the surgical team proceeded to remove the gelpoint v-path, ligate the uterine vessels, and then reattach the gelpoint v-path and continue with the procedure.Patient status: patient is feeling great and no concerns.

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 Description

Name of procedure performed: vaginally assisted notes hysterectomy.Description of event: bleeding was reported after placement of the alexis ring, before the gelseal cap was attached.This obscured the field of vision, shortly after which the surgical team proceeded to remove the gelpoint v-path, ligate the uterine vessels, and then reattach the gelpoint v-path and continue with the procedure.The alexis ring was placed using the doyen retractor and the surgeon's fingers.The patient was ~70years of age, with poor tissue elasticity, and the surgeon thought perhaps this could have impacted the placement of alexis and caused the uterine vessels to tear.No changes in health, just bleeding as described above, which was addressed and then the procedure continued as planned.Additional information received via email on 06apr2022 from [name], applied medical assoc cd mgr: this was the 1st or 2nd vnotes procedure done by the surgeon.The surgeon cut the uterosacral ligaments as usually done during vnotes and placed the sutures.No comments about the colpotomy creation.The alexis was inserted manually.The bleeding started after the alexis was placed.Bleeding came through the alexis posteriorly.Not an exact answer given but estimated between 100ml and 200ml.The bleeding was progressive.There was not an exact injury that could be identified by the tm or mentioned by the surgeon.However, the surgeon mentioned that due to the patient's age and the lack of elasticity of the tissue, he thinks this is what caused the bleeding of the vessels.Surgeon doesn't relate the incident to the product.No vessel sealing device was used prior to inserting the alexis.When the procedure continued, [name] was used tm doesn't recall how the bleeding was stopped but to complete the procedure, [name] was used during the laparoscopic phase.None (regarding additional details about patient anatomy that might have made the access challenging) there are no concerns from the surgeon related to the product or the procedure.He did at least one more vnotes case after this one and everything went well.As per tm's information, the surgeon relates the incident to patient anatomy.Initial insertion of the alexis was done manually.After the bleeding was stopped and the procedure could continue, surgeon inserted the alexis manually once more but couldn't feel that it was placed correctly.He then proceeded to attempt the insertion with the introducer which allowed him to correctly place the alexis.He said the introducer facilitated the insertion and now uses it routinely rather than using manual insertion.Intervention: the surgical team proceeded to remove the gelpoint v-path, ligate the uterine vessels, and then reattach the gelpoint v-path and continue with the procedure.Patient status: patient is feeling great and no concerns.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.Upon further investigation and additional information received, applied medical confirmed with the healthcare facility that the patient injury was not attributed to an applied medical device.

• Brand Name: C2A12, GELPOINT V-PATH PLATFORM, 9.5CM
• Type of Device: CULDOSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 13656555
• MDR Text Key: 290545640
• Report Number: 2027111-2022-00435
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K191294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C2A12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR