MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO DISSECT; MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

Model Number	174213
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, pre-operatively of a rectal procedure, when the device was opened, the flexible part at the tip was already broken.Another device was used to complete the case.There was no patient involvement.
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the plastic cable sheath had shearing damage.Functional evaluation found that the jaw rotation worked without difficulty; re lease lever, ratchet button and jaw toggle functioned properly; and, jaw articulated, opened and closed without difficulty.It was reported that the sheath was broken.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: endoscopic procedures should be performed only by physicians having adequate training and familiarity with endoscopic techniques.Consult the medical literature relative to complications, hazards and techniques, prior to performing endoscopic procedures.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.

• Brand Name: ENDO DISSECT
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 10606363
• Report Number: 2647580-2020-03188
• Device Sequence Number: 16746613
• Product Code: GET
• UDI-Device Identifier: 10884523000665
• UDI-Public: 10884523000665
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K914753
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 174213
• Device Catalogue Number: 174213
• Device Lot Number: P8K1474X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1