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

Catalog Number MCS20

Device Problems Positioning Failure (1158); Misfire (2532); Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.

Event Description

It was reported that during an unknown procedure, there were multiple issues with the clips; two at the same time, then no clip that released upon firing, clips that fell out and clips that didn't hold on well.Another like device was used to complete the procedure.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).Device evaluation sent for this report number 3005075853-2017-01157 sent in error.Evaluation belongs to report # 3005075853-2017-00697.

Manufacturer Narrative

(b)(4).Batch # n93470.The analysis results found that the mcs20 device was returned with a clip in the jaws.In addition, the tyvek was returned for analysis.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, the device was cycled and it fed and formed 1 conforming clips and it ejected 3 clips.In the next actuations, no clips were fed into the jaws.Upon inspection, the floor was found damaged causing the feeding issue.No conclusion could be reached as to what may have caused the feeding incident.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: LIGACLIP MCA SMALL APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 6372246
• MDR Text Key: 69155444
• Report Number: 3005075853-2017-01157
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: MCS20
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/22/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/20/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1