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

Catalog Number 544240

Device Problem Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2020

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 (b)(6) 2020 the clip fell off during ligating the tissue.Then remove the clip immediately and changing a new clip to complete the surgery.The patient is fine.

Manufacturer Narrative

(b)(4).Per dhr the product hemolok l clips 6/cart 84/box lot# 73h1900416 was manufactured on 08/19/2019 a total of (b)(4) pieces.Lot was released on 08/29/2019.Dhr investigation did not show issues related to complaint.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.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.

Event Description

It was reported that (b)(6) 2020 the clip fell off during ligating the tissue.Then remove the clip immediately and changing a new clip to complete the surgery.The patient is fine.

Manufacturer Narrative

Qn#(b)(4).The customer returned one cartridge 544240 hemolok l clips 6/cart 84/box for investigation.Additionally, two loose clips were also returned.The clip cartridge and loose clips were visually examined with and without magnification.Visual examination revealed that the cartridge was returned with four intact clips remaining.Both loose clips had a divot in the hook and some unknown green material on them.The divots are indicative that damaged or misaligned appliers were used on the clips.The appliers were not returned.Functional inspection was performed on the intact clips.A lab inventory applier was used.All four remaining clips were able to properly load into the applier and were successfully applied to over-stressed surgical tubing.The divots on the two loose clips are indicative that using a damaged or misaligned applier caused this complaint issue.The ifu for this product, 220002422, 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 "loaded clip is insecurely seated" was confirmed based upon the sample received.One cartridge with 4 intact clips was returned with two loose clips.Both loose clips had a divot in the hook.The divots are indicative that damaged or misaligned appliers were used on the clips.Using damaged or misaligned appliers could prevent the clips from staying seated in the jaws of the applier.Upon functional inspection, the four clips remaining in the cartridge functioned properly.It is unknown how the returned clips were handled during use and the appliers used at the time of malfunction were not returned for investigation.A device history record review was performed on the device and showed no evidence to suggest a manufacturing related issue.Therefore, based upon the damage observed, unintentional user error caused or contributed to this event.

Event Description

It was reported that(b)(6)2020 the clip fell off during ligating the tissue.Then remove the clip immediately and changing a new clip to complete the surgery.The patient is fine.

• Brand Name: HEMOLOK L CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10311006
• MDR Text Key: 200016964
• Report Number: 3003898360-2020-00601
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2020

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 Catalogue Number: 544240
• Device Lot Number: 73H1900416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 07/24/2020; 08/21/2020
• Supplement Dates FDA Received: 07/28/2020; 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1