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

Model Number IPN915184

Device Problem Break (1069)

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

Event Date 12/09/2021

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

When the user attempted to ligate a clip during a surgery it got broken.Therefore, a new cartridge was opened instead.Nothing fell/remained in the patient.

Manufacturer Narrative

Qn#(b)(4).Per dhr the product hemolok l clips 6/cart 84/box lot# 73l2000571 was manufactured on 11/24/2020 a total of 15,120 pieces.Lot was released on 12/09/2020.Dhr investigation did not show issues related to complaint.P/n 544240 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: 125 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.Revision of pfmea-08-025 rev 05 was performed and the failure mode is already including it, no update is required.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.

Event Description

When the user attempted to ligate a clip during a surgery it got broken.Therefore, a new cartridge was opened instead.Nothing fell/remained in the patient.

Event Description

When the user attempted to ligate a clip during a surgery it got broken.Therefore, a new cartridge was opened instead.Nothing fell/remained in the patient.

Manufacturer Narrative

Qn#(b)(4).The customer returned one clip from unit 544240 hemolok l clips 6/cart 84/box for investigation.The cartridge was not returned.The clip was visually examined with and without magnification.Visual examination revealed that the clip had both of its pierced bosses broken off.There was a divot on the hook and another divot on the hook bosses.R & d engineering was consulted for this complaint issue.According to r & d, the observed damage to the broken clip is consistent with improper loading of the clips or with using damaged appliers.The appliers were not returned for investigation.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/detached parts - clip - boss" was confirmed based upon the sample received.One loose clip was returned with both pierced bosses broken and divots on the hook and hook bosses.R & d was consulted for this complaint and it was determined that the observed damage to the broken clips is consistent with improper loading of the clips 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.

• Brand Name: HEMOLOK L 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: 12983698
• MDR Text Key: 282106299
• Report Number: 3003898360-2021-01118
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704695939
• UDI-Public: 24026704695939
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/10/2021

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: IPN915184
• Device Catalogue Number: 544240
• Device Lot Number: 73L2000571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 12/13/2021
• Supplement Dates Manufacturer Received: 12/13/2021; 01/28/2022
• Supplement Dates FDA Received: 01/09/2022; 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• 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
• Treatment: N/A.; N/A.