MAUDE Adverse Event Report: INTEGRA YORK, PA INC. JACOBSON PETITPOINT MOSQ 5 CVD; N/A

Catalog Number 105089

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

Medwatch with uf/importer report number (b)(4) was received on 09sep2019 with the following information: during a scheduled pacemaker case on (b)(6) 2019, the surgical technician grabbed the hemostats (id 105089 - jacobson petitpoint mosq 5 cvd) and attempted to grab the suture needle and was unable to obtain it.An (b)(6) male patient was being sutured at the time of incident.Upon looking at the hemostat, the technician noticed that a small piece of the tip fell off the hemostat onto the sterile table.He proceeded to complete the task without the hemostat and removed the broken device from the sterile field.It was reported that the surgeon was able to complete the procedure.No patient harm and no additional treatment was needed.

Manufacturer Narrative

The device was not returned for evaluation.The lot number was not provided to perform device history record review.A failure analysis and determination of root cause is not possible due to the product has not been received to perform a complete investigation.The reported complaint is unconfirmed.Device identifier :(b)(4).

Event Description

N/a.

• Brand Name: JACOBSON PETITPOINT MOSQ 5 CVD
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362319
• MDR Report Key: 9130916
• MDR Text Key: 166403471
• Report Number: 2523190-2019-00117
• Device Sequence Number: 1
• Product Code: HRQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

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 Catalogue Number: 105089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 11/07/2019
• Supplement Dates FDA Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 83 YR