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

Catalog Number B12LT

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.We did not receive a batch or lot number for the product involved in this complaint.Therefore, a device history could not be done additional information received: a fraction of the valve got caught on the forceps and fell outside the patient.No pieces fell into the patient.

Event Description

It was reported that during a laparoscopic esophagectomy, the forceps touched the valve and the valve broke off.Another device was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Batch # unknown.Device analysis: the analysis results found that the b12lt device was returned with the duckbill damaged and torn; the torn piece of the duckbill was returned.In addition, the obturator was not returned for analysis.The device was visually inspected, in order to evaluate the condition of the duckbill and the damage was confirmed; in addition, the separate piece of the duckbill was observed to have a mark which suggest that a pointy instrument was inserted through the trocar with excessive force.Per instructions for use: "use caution when introducing or removing instruments through the trocar sleeve in order to prevent inadvertent damage to the seals which could result in loss of pneumoperitoneum.Special care should be used when inserting sharp or angled edged endoscopic instruments to prevent tearing the seal." we did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformances.

• Brand Name: ENDOPATH XCEL BLADELESS TROCAR
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7037613
• MDR Text Key: 93093771
• Report Number: 3005075853-2017-06148
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B12LT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1