MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES; CULDOSCOPE (AND ACCESSORIES)

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Name of procedure performed: vnotes detailed description of event: i wanted to come back to you on the input you shared earlier this week regarding the v-path introducers and the alexis ring ending up in other locations then intended additional information received from applied medical representative via phone on 09-nov-2021: the introducer caused a large tear towards the rectum.Additional information received from applied medical representative via phone on 09-nov-2021: the awareness date is october 23, 2021, it was discussed during an informal conversation between the representative and the surgeon.The event date is unknown.It was a vnotes case.The event resulted in a rectal tear.The surgeon mentioned that the patient was previously operated in the abdominal area, and so post surgical adhesions were present and the surgeon felt that this may have contributed to the tear, but that they felt that the introducer may have contributed to an excessive force being used.It was not certain that the force used was excessive, as this is difficult to confirm.The rectal tear did not result in any consequence or risk to the patient, and the tear was controlled through normal procedural methods.Patient status: the rectal tear did not result in any consequence or risk to the patient.Type of intervention: normal procedural methods.

Manufacturer Narrative

Upon further investigation and additional information received from the healthcare facility, applied medical confirmed with the healthcare facility that no adverse event had occurred that was associated with applied medical¿s devices.

Event Description

Name of procedure performed: vnotes.Detailed description of event: i wanted to come back to you on the input you shared earlier this week regarding the v-path introducers and the alexis ring ending up in other locations then intended.Additional information received from applied medical representative via phone on 09-nov-2021: the introducer caused a large tear towards the rectum.Additional information received from applied medical representative via phone on 09-nov-2021: the awareness date is october 23, 2021, it was discussed during an informal conversation between the representative and the surgeon.The event date is unknown.It was a vnotes case.The event resulted in a rectal tear.The surgeon mentioned that the patient was previously operated in the abdominal area, and so post surgical adhesions were present and the surgeon felt that this may have contributed to the tear, but that they felt that the introducer may have contributed to an excessive force being used.It was not certain that the force used was excessive, as this is difficult to confirm.The rectal tear did not result in any consequence or risk to the patient, and the tear was controlled through normal procedural methods.Additional information received from applied medical clinical development representative via email on 12-nov-2021: when bringing this up with amr cd, they mentioned a conversation with a surgeon ¿ the contact for (b)(4) that took place earlier this week and before the cers were submitted.The surgeon shared his experience about a bowel tear case.Turns out, that the patient of this case had previous surgery and a lot of adhesions.Although the surgeon initially said that he had a complication with the introducer, he later clarified that he thinks he made the hole prior to inserting the alexis.This was a case with a gelpoint v-path c2a15.The team thinks this conversation is about the same case of the cer and is important to note that the surgeon doesn't attribute this to the device.The surgeon also commented that while proctoring a case, he noticed the surgeon had perforated the bladder but did not initially notice and proceeded to insert the alexis.He thinks it¿s possible that surgeons will blame the introducer for injuries made during colpotomy creation.Nonetheless, he advocates for keeping the doyen in while inserting the alexis as a layer of protection and trains surgeons this way during courses where he¿s faculty.Additional information received from applied medical clinical development representative via email on 12-nov-2021: the bladder perforation was an example of an injury during colpotomy, but was not associated with the gelpoint v-path.Additional information received from applied medical field implementation representative via email on 19-nov-2021: during the dissection for the posterior colpotomy, due to extensive adhesions following previous surgery, the surgeon inadvertently caused a rectal injury.This was confirmed upon placement of the gelpoint vpath using the introducer.The rectal injury was repaired without any consequences for the patient.The injury was caused by the dissection prior to the placement of the introducer and not as a consequence of introducing the gelpoint vpath.The patient has made a full recovery.No device is being returned.The device was a c2a15 lot unknown.It was used during a vnotes adnexectomy.Patient status: the rectal tear did not result in any consequence or risk to the patient.Type of intervention: normal procedural methods.

• Brand Name: UNK
• 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: 12797755
• MDR Text Key: 281664598
• Report Number: 2027111-2021-00715
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2021
• 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