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

Model Number	01-0031
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, post-operatively on lap adrenalectomy, initially, an rf machine was used but the rf mat was unintentionally folded during positioning in a case.After the case, the mat was used but it showed detection even when the sponge counts were correct with rf machine (serial#: (b)(6)).A replacement machine was used (serial#: (b)(6) ) with the same mat which also revealed detection.The staff used the wand which cleared the count but per policy, an x-ray was taken with the negative result which delayed the case.
Additional Manufacturer Narrative
D10 concomitant product: 01-0043, console; model 200x (serial#:(b)(6) ); 01-0043, console; model 200x (serial#: (b)(6)).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Correction: b1, b2, h1 additional information: g3 new information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a serious injury.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during laparoscopic adrenalectomy.Initially, the rf mat was unintentionally folded during positioning.After the case, the mat was used but it showed detection even when the sponge counts were correct with rf machine x18asq.A replacement machine was used x18aoy with the same mat which also revealed detection.The staff used the wand which cleared the count but per policy, an x-ray was taken (negative) which delayed the case.The mat was checked which resulted in clear reading.On the next procedure with the same patient, patient was on supine position and the same mat was used.After the case, the count was correct but when the mat was used, it revealed detection again.The staff used the wand to verify the count and the machine x18aoy cleared the reading.Sponge, needle and instrument counts were reported to be correct twice and all rfa intact.Eventually, one of the mat was malfu nctioning which had clear detection but the other(mat) was positive.Xrays were negative for retained foreign body.

• Brand Name: SITUATE
• Common Device Name: 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: 19561046
• Report Number: 1717344-2024-01326
• Device Sequence Number: 20720346
• Product Code: LWH
• UDI-Device Identifier: 10884521700642
• UDI-Public: 10884521700642
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 01-0031
• Device Catalogue Number: 01-0031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 06/20/2024; 07/03/2024; 07/03/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 06/20/2024; 07/16/2024; 07/19/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTE ON H11
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 77 KG