MAUDE Adverse Event Report: COVIDIEN LP BARRX PRODIGI; APPLIER, SURGICAL, CLIP

Model Number ERD-TWSG

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, the primary grasper with wire was detached from the tissue.The physician successfully used a secondary grasper to place the wire back onto the tissue.The traction was not as desired therefore the physician used a second secondary grasper to make a tripod shape with wire.Traction was then good.At the end of the procedure, the physician attempted to use grasping forceps to remove the secondary graspers from the healthy tissue.After two attempts where the forceps slipped off grasper body, the physician determined that they would prefer to just leave the graspers behind rather than continue trying to remove it.Technical support explained to the physician that the (ifu) instruction for use recommended to remove all components.Clutch cutters were used to cut the traction wire.The wire and graspers on the lesion were removed without an issue.The two secondary graspers that were atta ched to the healthy tissue were left in patient.The procedure was completed successfully and no reported issues.It was a three hour complex case.The physician placed wire and primary grasper per standard procedures.

Manufacturer Narrative

Additional information: g4, and added imf on codes.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.

Manufacturer Narrative

(b)(6) 21oct2020 communication received, update needed on rfnr from requested to customer discarded.Patient information updated as asked but unknown.Additional information: b5, g4, h6.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, the primary grasper with wire was detached from the tissue.The physician successfully used a secondary grasper to place the wire back onto the tissue.The traction was not as desired; therefore, the physician used a second secondary grasper to make a tripod shape with wire.Traction was then good.At the end of the procedure, the physician attempted to use grasping forceps to remove the secondary graspers from the healthy tissue.After two attempts where the forceps slipped off grasper body, the physician determined that they would prefer to just leave the graspers behind rather than continue trying to remove it.Technical support explained to the physician that the ifu (instruction for use) recommended to remove all components.Fuji clutch cutters were used to cut the traction wire.The wire and graspers on the lesion were removed without an issue.The two secondary graspers that were attached to the healthy tissue were left in patient.The procedure was completed successfully and no reported issues.It was a 3 hour complex case.The physician placed wire and primary grasper per standard procedures.

• Brand Name: PRODIGI
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• MDR Report Key: 10587301
• MDR Text Key: 208570760
• Report Number: 3004904811-2020-00031
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 20884521808383
• UDI-Public: 20884521808383
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ERD-TWSG
• Device Catalogue Number: ERD-TWSG
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention