MAUDE Adverse Event Report: APPLIED MEDICAL C7202, 5MMX33CM, EPIX REUSABLE PROBE; FHF

Model Number C7202

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The incident device anticipated to return.A follow-up report will be provided upon completion of investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.

Event Description

All laparoscopic cases- "having major issues with leakage with the new upgraded disposable hand piece.It looks like a blood bath after a laparoscopy.Leaking appears to be coming from hand piece but possible it could be coming from probes.Will be returning 4 reusable probes model #c7202, lot #1235810 along with new upgraded hand pieces for evaluation.Ed rudy went into account to observe issue and make sure everything was connect properly.Issue still present with proper connection." patient status- "as expected.".

Manufacturer Narrative

Corrections: full udi number added.Investigation summary: a reusable probe was returned for evaluation.Upon investigation, engineering found that the event unit functioned as designed when it was assembled with the sterile valve and tubing.There was no apparent leaking.The root cause of this event is likely due to probe cap design.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this continuous process, applied medical has improved the design of the probe cap to minimize the potential for this type of event to occur.In accordance to 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, a supplemental report will be submitted to the fda.

• Brand Name: C7202, 5MMX33CM, EPIX REUSABLE PROBE
• Type of Device: FHF
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer (Section G): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5033507
• MDR Text Key: 24259442
• Report Number: 2027111-2015-00593
• Device Sequence Number: 1
• Product Code: FHF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: C7202
• Device Catalogue Number: 101260701
• Device Lot Number: 1235810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 08/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1