MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK XL CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE

Model Number IPN915186

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2021

Event Type  malfunction  

Event Description

(b)(6) 2021, clip was found broken during using on the patient.The severed part has been removed from the patient with no adverse feedback.1 cartridge involved.

Manufacturer Narrative

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

Manufacturer Narrative

Qn#(b)(4).Per dhr the product hemolok xl clips 6/cart 84/box lot# 73a2000393 was manufactured on 01/20/2020 a total of (b)(4) pieces.Lot was released on 01/31/2020.Dhr investigation did not show issues related to complaint.P/n 544250 is not being manufactured currently, however, another part number from the same family was use for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 200 samples were taken from the current production p/n 544230 hemolok ml clips 6/cart 84/box lot # 73l2101095, the samples were visually inspected, and during the test issue reported "broken parts - clip - info not provided" was not observed in the current manufacturing process.Revision of pfmea-08-025 rev 05 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

(b)(6) 2021, clip was found broken during using on the patient.The severed part has been removed from the patient with no adverse feedback.1 cartridge involved.

Manufacturer Narrative

Qn# (b)(4).The customer returned one cartridge from unit 544250 hemolok xl clips 6/cart 84/box for investigation.Three loose clips and the packaging were also returned.The returned sample was visually examined with and without magnification.Visual examination revealed that the cartridge had two intact clips remaining.One of the loose clips had a gouge in the hook and the hook was also bent.The other loose clips were both intact and no abnormalities were observed.The returned sample appears used as there is biological material present on the device.The appliers were not returned for investigation.Functional inspection was performed on the clips in the cartridge and the two undamaged clips that were returned loose.A lab inventory applier was used.Both loose clips were manually loaded into the jaws of the applier and were successfully applied to over-stressed surgical tubing.The two clips in the cartridge were also able to properly load into the jaws of the applier and were also successfully applied to over-stressed surgical tubing.The observed damage to the hook of one of the clips is consistent with improper loading of the clips or with using damaged appliers.Therefore, unintentional user error appears to have caused or contributed to this issue.The ifu for this product, l02425, was reviewed as a part of this complaint investigation.The ifu states, "always check the alignment of the applier jaws before use.When closed, jaw tips should be directly aligned and not offset.Alignment of the jaw is critical for safe application of the clip.If this is not done, patient injury may occur.Proper maintenance, care and cleaning are necessary to ensure proper functionality." a corrective action is not required at this time as the damage observed on the clip indicates that unintentional user error caused or contributed to this event.The reported complaint of "broken parts - clip - info not provided" was confirmed based upon the sample received.Three loose clips were returned with a cartridge that contained two clips.One of the loose clips had a gouge in the hook and the hook was bent.The observed damage to the hook is consistent with improper loading of the clip or with using damaged appliers.It is unknown how the returned clip was handled during use and the appliers used at the time of malfunction were not returned for investigation.Therefore, based upon the damage observed, unintentional user error caused or contributed to this event.

Event Description

On (b)(6) 2021, clip was found broken during using on the patient.The severed part has been removed from the patient with no adverse feedback.1 cartridge involved.

• Brand Name: HEMOLOK XL CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville 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: 12983630
• MDR Text Key: 282105682
• Report Number: 3003898360-2021-01117
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704695953
• UDI-Public: 24026704695953
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2021

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 Model Number: IPN915186
• Device Catalogue Number: 544250
• Device Lot Number: 73A2000393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/13/2021
• Supplement Dates Manufacturer Received: 12/13/2021; 03/03/2022
• Supplement Dates FDA Received: 01/13/2022; 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1