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

Model Number 01-0043

Device Problem False Negative Result (1225)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a procedure, the unit had intermittent detection.When wanding the first trash bag, the wand indicated an rfd chip and we proceeded to find the missing lap in the bag.Still looking for the missing 4x8, two different nurses wanded the two remaining bags with no detection.A third nurse went through one of those wanded bags by hand and found the 4x8.Wanded the 4x8 to ensure the wand/rfd chip was still working and it did detect it, but outside of the bag.The wand was picking up rfd chips inconsistently.

Manufacturer Narrative

Additional information: b5, d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the device gave false negative detection.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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, during a procedure, the unit had intermittent detection.When wanding the first trash bag, the wand indicated an rfd chip and we proceeded to find the missing lap in the bag.Still looking for the missing 4x8, two different nurses wanded the two remaining bags with no detection.A third nurse went through one of those wanded bags by hand and found the 4x8.Wanded the 4x8 to ensure the wand/rfd chip was still working and it did detect it, but outside of the bag.The wand was picking up rfd chips inconsistently.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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12710189
• MDR Text Key: 278747402
• Report Number: 1717344-2021-01466
• Device Sequence Number: 1
• Product Code: LWH
• UDI-Device Identifier: 10884521700703
• UDI-Public: 10884521700703
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

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: 01-0043
• Device Catalogue Number: 01-0043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 11/23/2021
• Supplement Dates FDA Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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