MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH** XCEL*; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number B12SRT

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 04/19/2016.Additional information was requested and the following was obtained: was it part of a trocar seal that was also removed with the specimen? yes.If not, what part of device was removed with specimen? na.A photo of the sample was received for analysis.Upon visual inspection of the picture, it appears that a portion of the seal was damaged and dislodged from the assembly, through visual examination, it appears that the holes that serve to assemble the portion of the seal are torn, which suggests that the seal was properly assembled but somehow was dragged and forced through the sleeve; in addition, it appears that the portion of the seal has a dent, as if it was caught with a sharp device and dragged, causing the torn condition of the assembly hole and subsequent detachment from the assembly.Based on the photo evidence the event description can be confirmed.However, no conclusion could be reached as to the cause of the failure.

Event Description

It was reported that during a lap urological procedure, it was found that the valve of the trocar was damaged.Also, the doctor felt that a device was caught when a specimen was removed from the patient via the trocar.After that, it was found that the specimen was removed with a piece of a part.No pieces fell into the patient.Another device was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Additional information: batch # = n90622.The analysis results found that the b12srt was returned with one of the seals separated and was not returned for analysis.The instrument was disassembled and it was confirmed that one piece of the seal assembly was not returned for evaluation; the remaining pieces were noted to be properly assembled.A picture was provided, upon visual inspection of the picture, it appears that a portion of the seal was damaged and dislodged from the assembly, through visual examination, it appears that the holes that serve to assemble the portion of the seal are torn, which suggests that the seal was properly assembled but somehow was dragged and forced through the sleeve; in addition, it appears that the portion of the seal has a dent, as if it was caught with a sharp device and dragged, causing the torn condition of the assembly hole and subsequent detachment from the assembly.As the separated portion of the seal assembly was not returned for analysis, no further evaluation can be performed.One potential cause for the damage found may be the snagging of an instrument during insertion.No incident related to the reported event was observed during the batch record review.

• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5595121
• MDR Text Key: 44017475
• Report Number: 3005075853-2016-02201
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2016

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: 12/22/2020
• Device Catalogue Number: B12SRT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2016
• Initial Date FDA Received: 04/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2016
• 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