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

Model Number IPN915182

Device Problem Material Separation (1562)

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

Event Date 09/29/2021

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

During procedure the user found one or more green fragments in the patient's body.The user checked the cartridge to find there also were some fragments at around adhesive tape.He/she removed fragments using forceps from the patient as much as possible and before closing an incision he/she checked abdominal area under diagnostic imaging.No serious injury was reported.

Event Description

During procedure the user found one or more green fragments in the patient's body.The user checked the cartridge to find there also were some fragments at around adhesive tape.He/she removed fragments using forceps from the patient as much as possible and before closing an incision he/she checked abdominal area under diagnostic imaging.No serious injury was reported.

Manufacturer Narrative

(b)(4).Per dhr the product hemolok ml clips 6/cart 84/box lot# 73d2100032 was manufactured on 04/05/2021 a total of (b)(4) pieces.Lot was released on 04/15/2021.Dhr investigation did not show issues related to complaint.The customer returned one cartridge 544230 hemolok ml clips 6/cart 84/box for investigation.In addition to the cartridge, an obturator and a container with a small piece of green material inside it were returned.There were also three printed photos returned.The cartridge was returned with no clips remaining.The clip cartridge was visually examined with and without magnification.Visual examination of the returned cartridge revealed that there were multiple scrape marks on the cartridge and additional pieces of green material in the cartridge.The green material is part of the cartridge that has been scraped off.The obturator was found to have a small piece of green material inside it as well.Biological material was found on the returned devices, indicating that the samples were used.The damage observed to the cartridge is consistent with improper loading technique or with using damaged/misaligned appliers.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 cartridge indicates that unintentional user error caused or contributed to this event.The reported complaint of "broken/detached parts - cartridge" was confirmed based upon the sample received.The cartridge was received with multiple scrapes.A piece of green material was returned in a container and an obturator was returned with another piece of green material inside it.The green material was pieces of the cartridge that had been scraped off.The damage found to the cartridge is consistent with damage that can be caused when an applier is not properly inserted into the slots to retrieve a clip or when a damaged/misaligned applier is used.Based upon the observed damage, unintentional user error caused or contributed to this event.

• Brand Name: HEMOLOK ML 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: 12632213
• MDR Text Key: 276388199
• Report Number: 3003898360-2021-00990
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704695915
• UDI-Public: 24026704695915
• 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
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915182
• Device Catalogue Number: 544230
• Device Lot Number: 73D2100032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2021
• 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