XCEL DILATING TIP TROCAR

MDR report key: 3894509 · Received June 25, 2014

Report

Report Number: 3005075853-2014-04379
Event Type: Malfunction
Date Received: June 25, 2014
Date of Event: May 29, 2014
Report Date: June 3, 2014
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GCJ
PMA / PMN Number: K032676
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

Additional Manufacturer Narrative · 1

(B)(4). ADDITIONAL INFORMATION: THE COMPLAINT INDICATED A HOLE IN THE PACKAGING. THE D11LT PACKAGE WAS VISUALLY EXAMINED. DENTS CAUSED BY AN IMPACT AGAINST THE PACKAGE WERE PRESENT IN THE FMP LID STOCK THAT ALIGNED WITH THE EDGES OF THE DEVICE. THE PACKAGE WAS OPENED TO VIEW THE AREA UNDER MAGNIFICATION AND FMP APPEARED TO BE INTACT. THE DAMAGED AREAS WERE DYE TESTED PER TM5016 AND NO SEAL INTEGRITY DEFECT WAS IDENTIFIED. THE DYE POOLED ON THE MATERIAL AND DID NOT FLOW THROUGH. THIS INDICATES THAT NO HOLE WAS PRESENT. THE FMP MATERIAL IS FLEXIBLE AND HAD BECOME STRETCHED, BUT NO BREACH OF STERILITY OCCURRED. THE ISSUE IS COSMETIC ONLY. THE COMPLAINT EVENT FOR A HOLE IS NOT CONFIRMED.

Description of Event or Problem · 1

IT WAS REPORTED THAT PRIOR TO AN UNKNOWN PROCEDURE, AFTER OPENING THE SALES UNIT BOX, IT WAS NOTED THERE WAS A HOLE IN THE PLASTIC BLISTER OF THIS DEVICE. STERILITY WAS REPORTED TO BE COMPROMISED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
371234	XCEL DILATING TIP TROCAR	LAPAROSCOPE, GENERAL AND PLASTIC SURGERY	GCJ	ETHICON ENDO-SURGERY, LLC.	NA	J4A905

Patients

Seq	Age	Sex	Outcome	Treatment
1