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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL CORONARY SCISSORS 120DEG 7"; SCISSORS, GENERAL, SURGICAL
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TELEFLEX MEDICAL CORONARY SCISSORS 120DEG 7"; SCISSORS, GENERAL, SURGICAL Back to Search Results
Catalog Number 352168
Device Problem Break (1069)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/09/2019
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: during the surgery, when we applied scissors on the patient.One of the tips of the scissors suddenly came out.It is very shocking that scissors tip broke while applying it on patient.There seems to be serious manufacturing defect in the scissors and are required to be replaced immediately.Follow-up information states that the event occurred prior to use, the device was used per instructions, no intervention was required and there was no patient harm.
 
Event Description
It was reported that: during the surgery, when we applied scissors on the patient.One of the tips of the scissors suddenly came out.It is very shocking that scissors tip broke while applying it on patient.There seems to be serious manufacturing defect in the scissors and are required to be replaced immediately.Follow-up information states that the event occurred prior to use, the device was used per instructions, no intervention was required and there was no patient harm.
 
Manufacturer Narrative
Qn#(b)(4).Per dhr the product auto endo5 ml lot # 73l1800731 was manufactured on 11/26/2018 a total of (b)(4) pieces.Lot was released on 12/06/2018.Dhr investigation did not show issues related to complaint.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the sample was returned with its rotation tab bent and its jaws partially closed.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 could be heard indicating that the internal ratchet ears are intact.The first clip was unable to properly load as it got stuck in the bent rotation tab.After manually removing the clip and completing the trigger cycle, the next clip was protruding from the channel.The sample was disassembled to inspect the internal components.Upon disassembly, it was found that the clips were out of position and stacking on one another.The clip stacking could prevent the clips from properly loading into the jaws.The sample was received with 10 clips remaining in the channel indicating that 5 clips were fired by the end user.A capa has been opened to further investigate this issue.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." the reported complaint of "can't be separated from applier" was confirmed based upon the sample received.The device was returned with its rotation tab bent.The sample was returned with 10 clips remaining in the channel indicating that 5 clips were fired by the end user.Upon functional inspection, it was found that the clips were out of position and stacking on one another which prevented the clips from loading properly into the jaws of the device.Although the reported complaint issue was confirmed based on functional testing, it could not be determined exactly how or when the clips became out of position.A capa has been opened to further investigate this issue.
 
Event Description
It was reported that: during the surgery, when we applied scissors on the patient.One of the tips of the scissors suddenly came out.It is very shocking that scissors tip broke while applying it on patient.There seems to be serious manufacturing defect in the scissors and are required to be replaced immediately.Follow-up information states that the event occurred prior to use, the device was used per instructions, no intervention was required and there was no patient harm.
 
Manufacturer Narrative
Qn# (b)(4).This is a corrected follow-up report, including the "corrected additional manufacturer narrative." please make a note of it (see below): the device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 352168.A dimensional inspection was not required as part of this investigation.The device is not functional in current state.Damage is consistent with improper handling.Based on the visual review of the fracture plane and the customer's event description- it is very likely that this device was damaged in cleaning and was not adequately inspected prior to use on the patient.
 
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Brand Name
CORONARY SCISSORS 120DEG 7"
Type of Device
SCISSORS, GENERAL, SURGICAL
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key8960033
MDR Text Key156720463
Report Number3011137372-2019-00290
Device Sequence Number1
Product Code LRW
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 08/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number352168
Device Lot NumberC6
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Treatment
N/A.; N/A.
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