MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*MCA MED LONG APPLIER; CLIP, IMPLANTABLE

Model Number MCM30

Device Problems Mechanical Problem (1384); Failure to Form Staple (2579); Failure to Fire (2610)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 12/16/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch #: unk.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.Additional information was requested and the following additional information was received: what was the initial procedure? total thyroidectomy.What was the anatomical location of the clips? neck, upper thyroid artery, collateral vessels from lateral neck to thyroid gland.All clips were assisted with vicryl 2/0 times 2 to secure hemostasis.Did these clips not hold? either the instrument was not delivering clips or clips were delivered in fully opened position or were partially closed with a gap in the middle.Did these clips not hold? only the medium size.Were any clips noted to be partially open or malformed in the initial procedure? yes, there were malformed clips noted in both first and second procedure (initial operation and re-operation).If so, did surgeon continue using this same device that fired malformed clips? no, i changed device until i found one that was delivering the correct clips.As said before, i used vicryl 2/0 as well.Unfortunately the patient bled from the only deep vessels i could not ligate with vicryl 2/0 from the lateral neck side.Did clips fall off in the initial procedure? yes they did.If so, did surgeon continue using this same device that applied clips that fell off? no, i changed device as stated above.Did the patient have any co-morbidities that would affect the condition of patient¿s tissue? no, the patient did not have comorbidities.What is the current status of the patient? the patient has been discharged and is alive.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported the clips didn¿t hold and came loose during a total thyroidectomy procedure and post-surgery.Clip applier did not deliver clips and if delivered they were semi-opened.Patient bled and developed acute hemorrhage requiring further emergency surgery/extra surgical procedure (re-operation) fifteen minutes from previous elective procedure.The surgeon used a different approach during the re-operation.Some clips were found dislodged/lost from original position and bleeding point found unclipped.Surgery was prolonged by ninety minutes.Patient also required prolonged length of stay in hospital (length of hospital stay unknown).The patient has since been discharged.

Manufacturer Narrative

(b)(4).Date sent: 2/8/2022.D4: batch # v95k3j.H2: additional information received: the rep reported he was not present in procedure and was told later of device issue.The surgeon was an ent surgeon.Surgeon felt clips were loose or "slippery" meaning he felt the clips were not holding surgeon said device had different feel.They reported they used a lot of clips.During reoperation, the surgeon manually sutured.It was reported clips were malformed/semi open in earlier additional information received and in later additional information received, it was reported no clip.Malformations were noted.Surgeon reported clips not fully compressing.Rep reported device handle color was all white.Rep was unsure of vessel size that was being clipped.Surgeon is very experienced surgeon.Surgeon is currently using reusable devices due to backorder issues.Investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Upon visual analysis of the returned sample, it was determined that the mcm30 device was received with no damage to the external components.Upon cycling, the instrument was noted to be empty and locked out.The instrument is designed to lockout after all the clips have been fired; therefore a potential cause for the customer reported experience is the firing of all of the clips.As a result, the instrument could no longer be fired due to the activation of the lockout mechanism.As the device was returned empty for evaluation, we are unable to investigate further the issue of ¿malformed clips" and ¿would not hold".The device was disassembled to verify the condition of the internal components and no anomalies were noted.The event described could not be confirmed as the device was returned empty and no product defect was identified.As part of our quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 5/31/2022.Additional information received: incident / failure description: medium ligaclips multiple clip applier were used during the operation.All of the clips were faulty as verbalized by surgeon.Some clips does not fully close and some does not reload immediately.Incident / failure description: during surgery we identified faulty ligaclips (instrument not delivering clips, delivering semi-opened clips.Clips were changed multiple times but the entire lot of instruments was faulty.As a consequence of it the patient developed immediate post-op bleeding and required second surgery to evacuate a large hematoma of the neck.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 13256726
• MDR Text Key: 288053481
• Report Number: 3005075853-2022-00294
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002482
• UDI-Public: 10705036002482
• Combination Product (y/n): N
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2022

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: MCM30
• Device Catalogue Number: MCM30
• Device Lot Number: 435A72
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/13/2022
• Supplement Dates Manufacturer Received: 01/27/2022; 05/06/2022
• Supplement Dates FDA Received: 02/08/2022; 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization