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

Catalog Number HAP02

Device Problem Tears, rips, holes in device, device material (1628)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The analysis results found that the hap02 device was received with the iris seal torn.The initiation site appeared to be from lower ring and propagated to upper inner ring in two different places.However, it could not be determined what may have caused this condition.A batch record review was performed and the batch had no anomalies noted during the manufacturing process.

Event Description

It was reported that during a laparoscopic donor nephrectomy, the surgeon opened the dextrus seal cap assembly and the rubber connector was torn.Device was deemed unusable.Opened a new device to complete the procedure.No delay to procedure.No adverse event to patient.

Manufacturer Narrative

(b)(4).

• Brand Name: ENDOPATH DEXTRUS
• 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 0096 9
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3790231
• MDR Text Key: 12112722
• Report Number: 3005075853-2014-03032
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K070198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2018
• Device Catalogue Number: HAP02
• Device Lot Number: K4DK36
• Other Device ID Number: BATCH # K92A1N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2013
• 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