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

Model Number MCM30

Device Problems Delivered as Unsterile Product (1421); Difficult to Open or Close (2921); Difficult to Open or Remove Packaging Material (2922); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Date of event is 2020.Event day and event month were not reported.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.Additional information: a photo was received for review.Review is in progress.Upon completion of review, a supplemental medwatch will be sent containing the additional information regarding findings from photo review.Attempts are being made to obtain the device.To date no response has been provided.If the device or further details are received at a later date, a supplemental medwatch will be sent.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 that during an open stomach procedure, the instrument could not be removed sterilely.The peel-up film was glued up to the edges with adhesive.The adhesive had to be removed with a scalpel between the blister and the peel-up film before the product could be removed from the packaging, so the product was no longer sterile.There was no harm to the patient.

Manufacturer Narrative

(b)(4).Date sent: 10/5/2020 d4: batch # unk additional information: a photo was received for review.Upon visual inspection of one photo, the following was observed: the photo shows a device partially opened and evidence of adhesive on "peel here" area was noted.The package belongs to product code mcm30, lot # u40599, exp.Date: 2025-02-28.Based on the photo, the event describe is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event, however, as no device has yet been received, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.

Manufacturer Narrative

(b)(4).Date sent: 12/3/2020.D4: batch # unk.Investigation summary: the analysis results found that a mcm30 package was returned opened.Upon visual inspection the blister was noted to have evidence of adhesive on the "peel here area." also, the seal area was examined for visual inspection and was noted to be complete.The seal area was noted to be without any anomalies.This condition is related to the manufacturing process.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10603663
• MDR Text Key: 209180264
• Report Number: 3005075853-2020-05035
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCM30
• Device Catalogue Number: MCM30
• Device Lot Number: U40599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 11/05/2020
• Patient Sequence Number: 1