MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ROTATING MULTIPLE CLIP APPLIER; CLIP, IMPLANTABLE

Catalog Number ER320

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event, and is being considered not reportable.

Manufacturer Narrative

(b)(4).Additional information: the analysis results for the er320 device found that it was returned with the shaft bent.No functional testing could be performed due to the returned condition of the device.Possible causes for the damage found may be inadvertent pressure placed on the device shaft through bending, pressing against the trocar, other devices on the back table, using the device as a retractor or moving heavy tissue with the device shaft.However, it could not be determined what to may have caused the reported incident.The batch record was reviewed and no anomalies were noted during the manufacturing process.

Event Description

It was reported that during an unknown procedure, the tip was bent on the device.It is unknown how the case was completed.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: how was the procedure completed? the bent part was noticed prior to any procedure being started.How was the procedure completed? never started with this product was there any patient consequence? no.

• Brand Name: ROTATING MULTIPLE CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3920010
• MDR Text Key: 12053837
• Report Number: 3005075853-2014-04761
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2014

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: 01/08/2019
• Device Catalogue Number: ER320
• Device Lot Number: L4E747
• Other Device ID Number: BATCH # L9092Y
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/11/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/22/2014
• Initial Date FDA Received: 07/08/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/25/2014; 07/25/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1