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

Catalog Number MCS20

Device Problems Failure to Form Staple (2579); Failure to Fire (2610); Mechanical Jam (2983)

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

Event Date 12/01/2023

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, clips not working while clipping.No patient consequences.

Manufacturer Narrative

(b)(4); date sent: 1/3/2024.B3: unknown, assumed first day of month that complaint was reported.D4: batch # unk.Additional information was requested and the following was obtained: ""please clarify how ¿clips not working while clipping¿ did device not feed clips? - yea.Did device feed clips sideways? - not properly.Did device not fire clips (jammed)? - yes.Did device fire malformed clips?- yes.Did device fire scissored clips? - not properly.Did device drop or eject clips? - clips jumps out.If other, please specify." an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 2/13/2024.D4: batch # a9d67d.Investigation summar: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the mcs20 device was returned with no apparent damage.In an attempt to replicate the reported incident, the instrument was cycled and in the next actuations, no clips were fed into the jaws even though the device was being actuated in several occasions.The device was disassembled in order to evaluate the condition of the internal components and the feeder shoe was noted be damaged.Seven(7) clips were found inside clip track.No conclusion could be reached as to what may have caused the reported incident.The reported complaint was confirmed.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.

• 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 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 18435966
• MDR Text Key: 331901765
• Report Number: 3005075853-2024-00036
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002499
• UDI-Public: 10705036002499
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 02/13/2024

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: MCS20
• Device Lot Number: 491C27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1