MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO CLINCH II; FORCEPS, OBSTETRICAL

Model Number 174317

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 06/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic myomectomy, when the device was entering by the trocar, without having been used yet, one of the leaves was detached.The component fell into patient¿s cavity.Resulted to unnecessary prolonged surgery with consequent prolonged anesthesia exposure.In addition, another surgical team had to be notified as the fragment was in the hepatic area.Another device was used to complete the case.

Event Description

According to the reporter, during a laparoscopic myomectomy, when the device was entering by the trocar, without having been used yet, one of the jaw was detached.The component fell into patient¿s cavity.A team extracted it and they continued with the surgery without damage.This resulted to unnecessary prolonged surgery with consequent prolonged anesthesia exposure.In addition, another surgical team had to be notified as the fragment was in the hepatic area.Another device was used to complete the case.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted the jaw of the device was broken at the fulcrum.Pmv performed functional testing and the jaw rotated without difficulty.Other functions of device could not be tested due to condition of device.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.Replication of the broken jaw may occur when the device is exposed to a side force (leverage) that consequently breaks one side of the jaws.Another possibility is when the device is activated with too much force to the jaws and is used in a twisting motion resulting in breakage.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 CLINCH II
• Type of Device: FORCEPS, OBSTETRICAL
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8776108
• MDR Text Key: 150561485
• Report Number: 2647580-2019-03587
• Device Sequence Number: 1
• Product Code: HDA
• UDI-Device Identifier: 10884523000832
• UDI-Public: 10884523000832
• Combination Product (y/n): N
• PMA/PMN Number: K903205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 174317
• Device Catalogue Number: 174317
• Device Lot Number: P9A1445Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other