MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE

Catalog Number AE05ML

Device Problems Leak/Splash (1354); Device Fell (4014)

Patient Problem No Information (3190)

Event Date 08/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that clips misfired or clips not aligning.Clips fall out.

Manufacturer Narrative

Qn# (b)(4).After an additional medical review, a determination was made to re-classify the complaint as a malfunction.Complaint (b)(4) is being reported as a malfunction.There was no serious injury.

Manufacturer Narrative

Qn# (b)(4).Per dhr the product auto endo5 ml lot # 73m1800272 was manufactured on 12/10/2018 a total of (b)(4) pieces.Lot was released on 12/21/2018.Dhr investigation did not show issues related to complaint.Revision of fmea-08-029 rev 04 was performed and the failure mode is already including it, no update is required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.

Event Description

It was reported that clips misfired or clips not aligning.Clips fall out.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8976799
• MDR Text Key: 156964514
• Report Number: 3003898360-2019-01137
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K152081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73M1800272
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/09/2019
• Supplement Dates Manufacturer Received: 09/09/2019; 09/09/2019
• Supplement Dates FDA Received: 10/14/2019; 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention