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

Catalog Number	EL214
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Attempts are being made to obtain the following information: can you please clarify "and clipped from ligated vessel."? as you had stated that the clips were not fully closed, can you clarify if the clips fell off of the vessels they were applied to? were there any patient consequences? 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.
Event or Problem Description
It was reported that during an unknown procedure, when surgeon applied each clip (lt200) to vessel, surgeon could see clips were not fully closed and clipped from ligated vessel."another applier wasn't made this problem but only happened it from this product." it is unknown how procedure was completed and patient consequence was not reported.

• Common Device Name: APPLIER, HEMOSTATIC CLIP
• 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9598832
• Report Number: 3005075853-2020-00379
• Device Sequence Number: 2475143
• Product Code: HBT
• UDI-Device Identifier: 10705036003847
• UDI-Public: 10705036003847
• Combination Product (Y/N): N
• PMA/510(K) Number: K830503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: EL214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 01/22/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown