MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO END05 ML; CLIP, IMPLANTABLE

Catalog Number AE05ML

Device Problems Bent (1059); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto end05 ml, lot #73f1600689 investigations did not show issues related to the complaint.The device investigation report has not been submitted at this time.The manufacturer will continue to monitor and trend related events.

Event Description

The metal loading arm in the jaws of the device was bent out of place and the nursing staff could not load any more clips after 3 had been used.The patient was not affected.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one unit ae05ml auto end05 ml for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the rotation tab is bent out of place.The returned device appears used as there is biological material present on the jaws of the device.No other defects or anomalies were observed.Reference files (b)(4) for investigation photos.Functional inspection was performed by attempting to load clips in the jaws of the device by engaging the trigger.Upon engagement of the trigger, no ratchet sound could be heard indicating that the internal ratchet ears are broken.The first clip was unable to load properly and resulted in the clip snapping into two pieces.Another attempt was made and the clip was again unable to load properly.However, it was able to close and release.The remaining clips were all unable to properly load into the jaws of the device, but were still able to close and release from the device.The returned sample was disassembled to look at the internal components.Upon disassembly, it was found that no further damage was observed beyond the rotation tab being bent out of place.The sample was received with 5 other remarks: clips remaining in the channel indicating that 10 clips were fired by the end user.The ifu for this product, l06072, was reviewed as a part of this complaint investigation.The ifu for this product states, "mishandling of appliers may result in improper load and/or closure of the ligating clip.Please examine the applier before surgery for potential damage paying particular attention to the jaws." a corrective action is not required at this time as the condition of the sample received indicates that operational context caused or contributed to this event.The reported complaint of "loading arm in jaws are bent" was confirmed based upon the sample received.One device was returned.Visual inspection revealed that the rotation tab was bent out of place.Upon functional inspection, the clips would not load into the jaws of the device properly due to the rotation tab being bent.At the time of manufacturing assembly, the autoend05 is 100% inspected for proper clip loading and closure.It is unlikely that this type of damage was present at the time of manufacturing.The device was received with 5 clips remaining in the channel indicating that the end user fired 10 clips.A device history record review was performed on the device with no evidence to suggest a manufacturing related issue.Therefore, based upon the damage observed and the information provided, operational context caused or contributed to this event.

Event Description

The metal loading arm in the jaws of the device was bent out of place and the nursing staff could not load any more clips after 3 had been used.The patient was not affected.The patient's condition was reported as fine.

• Brand Name: AUTO END05 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 6133070
• MDR Text Key: 61084877
• Report Number: 3003898360-2016-01090
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K152081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/07/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: AE05ML
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1