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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE
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TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE Back to Search Results
Catalog Number AE05ML
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/01/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.The device history review could not be conducted since the lot number was not provided.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the first clip was not loaded into the jaws properly during a laparoscopic uterus malignant tumor resection.Therefore, the device was replaced with a new one to complete the operation.It is unknown whether a clip fell/remained in the patient.Description will be updated once additional information is provided.
 
Event Description
It was reported that the first clip was not loaded into the jaws properly during a laparoscopic uterus malignant tumor resection.Therefore, the device was replaced with a new one to complete the operation.It is unknown whether a clip fell/remained in the patient.Description will be updated once additional information is provided.
 
Manufacturer Narrative
Qn#(b)(4).Per dhr the product auto endo5 ml lot # 73e1900683 was manufactured on 05/27/2019 a total of (b)(4)pieces.Lot was released on 06/04/2019.Dhr investigation did not show issues related to complaint.The customer returned one unit ae05ml autoend05 ml for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the sample appears used as there is biological material present on the device.Functional inspection was performed on the returned sample by attempting to engage the trigger using hand pressure.Upon engagement of the trigger, an audible ratchet sound was heard indicating that the internal ratchet ears are intact.The first clip was able to load properly into the jaws.An attempt was made to apply the clip onto over-stressed surgical tubing.However, the jaws became misaligned during closing.Another attempt was made with the same result.The sample was disassembled in order to inspect the internal components.It was found that the bottom jaw was bent.The clips were also out of position and stacking on one another in the channel.The sample was received with 7 clips remaining in the channel, indicating that the end user fired 8 clips.The damage to the jaw could prevent the clips from loading properly.It is unlikely that the clip stacking caused the observed damage to the jaw.It appears that an external force or side pressure was applied to the jaw, which caused it to bend.The device would be unable to load clips properly in this condition.If a clip misloads and is not manually cleared prior to loading another clip, the clips can be held up in the loading sequence and stack on one another in the channel.Therefore, based upon the damage observed, unintentional user error caused or contributed to this event.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.".A corrective action is not required at this time as the condition of the sample received indicates that unintentional user error caused or contributed to this event.The reported complaint of "clip not loading properly" was confirmed based upon the sample received.Upon functional inspection, the first loaded properly clips but was unable to be applied to over-stressed surgical tubing as the jaws became misaligned during closing.The sample was disassembled.The bottom jaw was bent.The clips were also out of position and stacking on one another in the channel.The observed damages to the jaw could prevent the clips from loading properly.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.A device history record review was performed on the device with no evidence to suggest a manufacturing related cause.Therefore, based upon the observed damage, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend reports of this nature.
 
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Brand Name
AUTO ENDO5 ML
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key9977981
MDR Text Key188249921
Report Number3003898360-2020-00376
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
PMA/PMN Number
K152081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 04/01/2020
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
Device Operator Health Professional
Device Expiration Date05/26/2022
Device Catalogue NumberAE05ML
Device Lot Number73E1900683
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2020
Initial Date Manufacturer Received 04/01/2020
Initial Date FDA Received04/20/2020
Supplement Dates Manufacturer Received05/12/2020
Supplement Dates FDA Received05/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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