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

Catalog Number ER320

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event: unknown.Batch # unk.A manufacturing record evaluation was performed for the finished device lot number r40d5w, and no non-conformances were identified.Additional information was requested, and the following was obtained: can you please clarify if the "holes in the packaging" compromised the sterility of the device? yes, the holes in the package compromised the sterility and another device had to be used.The device in question was never used as it was compromised.

Event Description

It was reported that before an unknown procedure, the er320 had holes that it went through that caused the holes in the packaging.It is unknown if another like device was used to complete the procedure.There were no adverse consequences for the patient.

Manufacturer Narrative

(b)(4).Batch # r92m1f.Device analysis: the analysis results found that er320 device was returned outside its original package.Only the tyvek was returned for analysis.Upon visual inspection, it was observed that the tyvek from the packaging was damaged; it was noted to have holes in the tyvek, the holes were noted to be from the outside in.Due to the damages found on the packaging, a possible cause for these conditions is due to improper handling during transit or storage; it appears that the package hit a pointy surface and this caused the reported event.The reported complaint was confirmed.All ees product is 100% inspected prior to release.The information you provided is compiled monitored and reviewed on a routine basis for any associated trends.A manufacturing record evaluation was performed for the finished device batch r92m1f number, and no non-conformances were identified.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8459668
• MDR Text Key: 140294736
• Report Number: 3005075853-2019-17611
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: 10705036012580
• Combination Product (y/n): N
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: ER320
• Device Lot Number: R40D5W
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/25/2019
• Date Manufacturer Received: 03/29/2019
• Patient Sequence Number: 1