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

Catalog Number 544230

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2019

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 lap/chole procedure the surgeon spotted minute bits of green inside patient's abdomen.Hem-o-lok cartridge noted to have chipped off pieces.Both pieces immediately removed from abdomen.No injury to patient.

Manufacturer Narrative

(b)(4).Per dhr the product hemolok ml clips 6/cart 84/box lot# 73d1900637 was manufactured on 04/24/2019 a total of (b)(4) pieces.Lot was released on 05/02/2019.Dhr investigation did not show issues related to complaint.The customer returned one cartridge 544230 hemolok ml clips 6/cart 84/box for investigation.The cartridge was returned with its lid stock.The applier was not returned.The cartridge was returned without its original packaging.The clip cartridge was visually examined with and without magnification.Visual examination of the returned cartridge revealed that there were no clips remaining in the cartridge.The returned cartridge appears used as there is biological material present on the device.Significant scrape marks were observed on the cartridge.During manufacturing assembly, the cartridges are 100% visually inspected.It is unlikely that this type of damage was present during manufacturing.R & d was consulted.The observed scrape marks on the cartridge are indications of improper loading or use of damaged appliers.Therefore, based upon the damage observed, unintentional user error caused or contributed to this event.The ifu for this product, l06110, 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." "to load the applier, grasp the applier and carefully insert the jaws of the applier into the cartridge slot, making sure the jaws are perpendicular to the base of the cartridge.Gently press the applier over the clip until there is an audible click.Do not force the applier into the cartridge or onto the clip.The applier should enter and withdraw from the cartridge easily." a corrective action is not required at this time as the damage observed indicates that unintentional user error caused or contributed to this event.The observed scrape marks on the cartridge are indications of improper loading or use of damaged appliers.The reported complaint of "broken/detached parts - cartridge" was confirmed based upon the sample received.One cartridge was returned with no clips remaining in it.Significant scrape marks were observed on the cartridge.R & d was consulted.The observed scrape marks on the cartridge are indications of improper loading or use of damaged appliers.During manufacturing assembly, the cartridges are 100% visually inspected.It is unlikely that this type of damage was present during manufacturing.A device history record review was performed and showed no evidence to suggest a manufacturing related issue.Therefore, based upon the damaged observed, unintentional user error caused or contributed to this event.

Event Description

It was reported that during lap/chole procedure the surgeon spotted minute bits of green inside patient's abdomen.Hem-o-lok cartridge noted to have chipped off pieces.Both pieces immediately removed from abdomen.No injury to patient.

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 9118513
• MDR Text Key: 160162394
• Report Number: 3003898360-2019-01195
• 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: other
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

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 Date: 04/22/2024
• Device Catalogue Number: 544230
• Device Lot Number: 73D1900637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 10/30/2019
• Supplement Dates FDA Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 108