MAUDE Adverse Event Report: AESCULAP AG DISP.SHARP RETR.TROCAR +2 CANN.D12/100MM; DISPOSABLE/SEMI-DISPOSABLE TROCAR S

Model Number LAPRO-EC12DL-AUTO

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

(b)(6).It was reported that the trocar had breakage after pneumoperitoneum installation.All med watch submissions related to ths report are: 9610612-2018-00233, 9610612-2018-00234, 9610612-2018-00263.

• Brand Name: DISP.SHARP RETR.TROCAR +2 CANN.D12/100MM
• Type of Device: DISPOSABLE/SEMI-DISPOSABLE TROCAR S
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7589066
• MDR Text Key: 111025467
• Report Number: 9610612-2018-00234
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LAPRO-EC12DL-AUTO
• Device Catalogue Number: LAPRO-EC12DL-AUTO
• Device Lot Number: 8551605257
• Distributor Facility Aware Date: 06/04/2018
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other