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

Catalog Number MSM20

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2018

Event Type  malfunction  

Manufacturer Narrative

Pc-(b)(4).Batch # r92j4n.Device analysis: the analysis results found that the msm20 device was returned with no damage in the external components.In addition, the tyvek was returned along with the instrument.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 the remaining 5 clips as intended.As the device was found to be fully functional, it could not be determined what may have caused the reported incident.No conclusion could be reached as to what may have caused the reported incident.The reported complaint could not be confirmed.The lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the packaging process.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.Additional information requested and received: did the clip drop from the jaws of the device? yes.Did the clips fall off the vessel after being placed? yes.

Event Description

The clips slide off the clamp.There were no patient consequences.

• 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8106044
• MDR Text Key: 129073674
• Report Number: 3005075853-2018-14580
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002505
• UDI-Public: 10705036002505
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2018

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 Expiration Date: 02/28/2023
• Device Catalogue Number: MSM20
• Device Lot Number: R4070G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1