MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER SITUATE; COUNTER, SPONGE, SURGICAL

Model Number 01-0034

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2022

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical product: 01-0034 (brand name: console; rf assure model 200ld-v, serial number: (b)(4).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, post-operatively, the device had detection issue wherein it detected but sponge was not present.Baby was delivered.After vaginal sweep, the model l19kkq was used and a detection occurred.The nurse asked about the back table and all sponges were accounted for.The nurse then used model l19kkq again and a detection occurred once more.At that point, the physician did an additional vaginal sweep with no sponge located.Again, a count was done, and all sponges were accounted for.Another delivery scanner was brought in (model l19kkt) and once more, a detection occurred.The physician then left the room and another scan was done and this time, a clear scan was accomplished on the patient.After the clear scan was achieved, the director went into the room and scanned all who was in the room to look for a potential interference.Scanned the nurse, patient (again), and the husband, after doing so, all people in the room achieved a clear detection and no interferences occurred.The only person that was not scanned at that time was the physician.The physician was back to the hospital and scanned the room for interferences that could possibly cause a false positive by turning on all machines that were on during the vaginal delivery.Scanned everywhere and nothing triggered a false positive.After talking to the staff though, it was determined that not all staff were placed the scanner on the pubic bone before the scan button was pushed on the machine.There were sponges too close to the scanner and/or its cord therefore, user error.The nurse, who used the system in the vaginal delivery room stated that the scanner on the pubic bone first before pressing the button but could not remember if the scanner cord was near cotton or not.There was no patient injury.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, post-vaginal delivery, the device had detection issue wherein it detected but sponge was not present.Baby was delivered.After vaginal sweep, the model l19kkq was used and a detection occurred.The nurse asked about the back table and all sponges were accounted for.The nurse then used model l19kkq again and a detection occurred once more.At that point, the physician did an additional vaginal sweep with no sponge located.Again, a count was done, and all sponges were accounted for.Another delivery scanner was brought in (model l19kkt) and once more, a detection occurred.The physician then left the room and another scan was done and this time, a clear scan was accomplished on the patient.After the clear scan was achieved, the director went into the room and scanned all who was in the room to look for a potential interference.Scanned the nurse, patient (again), and the husband, after doing so, all people in the room achieved a "clear" detection and no interferences occurred.The only person that was not scanned at that time was the physician.The physician was back to the hospital and scanned the room for interferences that could possibly cause a false positive by turning on all machines that were on during the vaginal delivery.Scanned everywhere and nothing triggered a false positive.After talking to the staff though, it was determined that not all staff were placed the scanner on the pubic bone before the scan button was pushed on the machine.There were sponges too close to the scanner and/or its cord therefore, user error.The nurse, who used the system in the vaginal delivery room stated that the scanner on the pubic bone first before pressing the button but could not remember if the scanner cord was near cotton or not.There was no patient injury.

• Brand Name: SITUATE
• Type of Device: COUNTER, SPONGE, SURGICAL
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15371850
• MDR Text Key: 299406566
• Report Number: 1717344-2022-01080
• Device Sequence Number: 1
• Product Code: LWH
• UDI-Device Identifier: 10884521700659
• UDI-Public: 10884521700659
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

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
• Device Operator: Health Professional
• Device Model Number: 01-0034
• Device Catalogue Number: 01-0034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/07/2022
• Supplement Dates Manufacturer Received: 09/06/2022
• Supplement Dates FDA Received: 09/21/2022
• Date Device Manufactured: 11/08/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 81 KG