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

Catalog Number H12LP

Device Problem Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2015

Event Type  malfunction  

Event Description

It was reported that during a lap sigmoidectomy, the valve came off and fell into the h12lp.Another device was used to complete the case.No pieces fell into the patient.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).No device received for analysis at time of submission of 3500a when additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.Additional information was requested and the following was obtained: by valve, do you mean a trocar seal fell into trocar but not into patient? ---yes if not a seal, what component are you referring to as a "valve that fell into trocar?" --- na is the valve (or seal) being returned with rest of device for analysis? --- no information if valve (or seal) is not being returned, please provide reason that valve (or seal) is not being returned (was valve or seal discarded)? --- na.

• 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: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 4929939
• MDR Text Key: 21795986
• Report Number: 3005075853-2015-04466
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H12LP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1