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

Model Number C2A12

Device Problems Entrapment of Device (1212); Unintended Movement (3026)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/04/2023

Event Type  Injury  

Event Description

Procedure performed: hysterectomy.Event description: "the surgeon had some difficulty seating the alexis retractor.It took 3 attempts to insert via introducer - the surgeon did widen the colpotomy between insertion attempts.After the third insertion and before rolling down the alexis, she conducted a finger sweep and did not note any tissue entrapment, so she then rolled the outer ring of the alexis twice to retract it.After a few minutes, the surgeon visually noted some bleeding and noted that the adnexa (fallopian tube/ovary) were between the inner ring of the alexis and the peritoneum.The team noted that this was [name] first vnotes case and that she had been flustered going into this case - she was operating in a surgery center she was unfamiliar with and had equipment failures - so once she noted bleeding, she removed the device and converted to the minimally invasive approach she was comfortable with (a traditional vaginal hysterectomy) and completed the case that way." additional information was received via email on 14feb2023 from analyst ii, applied medical.Unknown what the lot number was.Product was not available for return as it was disposed of after the case additional information was received via email on 15feb2023 from clinical education specialist, applied medical incision size was "m".The rep also gave information that a doyens was also used during the procedure.Intervention: "she removed the device and converted to the minimally invasive approach she was comfortable with (a traditional vaginal hysterectomy) and completed the case that way." patient status: "the patient stayed overnight and recovered well.".

Manufacturer Narrative

No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Procedure performed: hysterectomy event description: "the surgeon had some difficulty seating the alexis retractor.It took 3 attempts to insert via introducer - the surgeon did widen the colpotomy between insertion attempts.After the third insertion and before rolling down the alexis, she conducted a finger sweep and did not note any tissue entrapment, so she then rolled the outer ring of the alexis twice to retract it.After a few minutes, the surgeon visually noted some bleeding and noted that the adnexa (fallopian tube/ovary) were between the inner ring of the alexis and the peritoneum.The team noted that this was [name] first vnotes case and that she had been flustered going into this case - she was operating in a surgery center she was unfamiliar with and had equipment failures - so once she noted bleeding, she removed the device and converted to the minimally invasive approach she was comfortable with (a traditional vaginal hysterectomy) and completed the case that way." additional information was received via email on 14feb2023 from analyst ii, applied medical unknown what the lot number was.Product was not available for return as it was disposed of after the case additional information was received via email on 15feb2023 from clinical education specialist, applied medical incision size was "m".The rep also gave information that a doyens was also used during the procedure.Intervention: "she removed the device and converted to the minimally invasive approach she was comfortable with (a traditional vaginal hysterectomy) and completed the case that way." patient status: "the patient stayed overnight and recovered well.".

• 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: 16482888
• MDR Text Key: 310684920
• Report Number: 2027111-2023-00365
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C2A12
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2023
• 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
• Treatment: DOYENS
• Patient Outcome(s): Other