MAUDE Adverse Event Report: AESCULAP (PRESTIGE) LAPAROSCOPIC ALLIS CLAMP

Model Number 9361-10

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

Patient Problem No Information (3190)

Event Date 12/09/2013

Event Type  Injury  

Event Description

Per op report: the arms of the laparoscopic allis device broke.One arm was immediately visualized and able to be removed without difficulty.The second arm was not visualized, after looking for the device in the immediate area and not finding it, x-ray was called in and an x-ray was performed.The piece was located in the left upper quadrant, near the liver, under bowel.It was removed without difficulty.(b)(4).

• Brand Name: LAPAROSCOPIC ALLIS CLAMP
• Type of Device: LAPAROSCOPIC ALLIS CLAMP
• Manufacturer (Section D): AESCULAP (PRESTIGE); 377 corporate parkway; center valley PA 18034
• MDR Report Key: 3731837
• MDR Text Key: 4276607
• Report Number: MW5035475
• Device Sequence Number: 1
• Product Code: NWV
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2014

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 Model Number: 9361-10
• Device Catalogue Number: 9361-10
• Device Lot Number: L 602
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 41 YR
• Patient Weight: 61