MAUDE Adverse Event Report: INTEGRA-JARIT INSTRUMENTS NEEDLE HOLDER

Device Problem Break (1069)

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

Event Date 04/15/2016

Event Type  Injury  

Event Description

A piece of the needle holder broke off while doing a posterior enterocele repair.Both pieces thought to be recovered.Manufacturer: please note that we do not send products to the manufacturer, but you may arrange for pick-up by calling my number below.

Event Description

Add'l info received from reporter on 07/28/2016 on report # mw5062959.(mfr info edited).

• Brand Name: NEEDLE HOLDER
• Type of Device: NEEDLE HOLDER
• Manufacturer (Section D): INTEGRA-JARIT INSTRUMENTS; 311 enterprise drive; plainsboro NJ 08536
• MDR Report Key: 5741397
• MDR Text Key: 48029758
• Report Number: MW5062959
• Device Sequence Number: 1
• Product Code: HXK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 07/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/27/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR