MAUDE Adverse Event Report: AESCULAP FLEXIMED GMBH MINOP ANGLED ENDOSCOPE 0DEG180MM 2.7MM

Model Number PE184A

Device Problem Image Resolution Poor (1306)

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

Event Date 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation is on-going.

Event Description

Two scopes were used in the same surgery.Type of procedure : endoscopic third ventriculostomy.Description of the issue noted during procedure: endoscopes looked clear when tested on the table, turned foggy when inserted into the brain.Approximate delay in procedure: 15 minutes.Third set of back up scopes were used to complete the surgery.No patient injury reported, they were able to complete the surgery.Related to medwatch report: 2916714-2015-01042.

• Brand Name: MINOP ANGLED ENDOSCOPE 0DEG180MM 2.7MM
• Type of Device: ENDOSCOPE
• Manufacturer (Section D): AESCULAP FLEXIMED GMBH; 1-3 robert-bosch-strasse; denzlingen, 79211 ; GM 79211
• Manufacturer (Section G): AESCULAP FLEXIMED GMBH; 1-3 robert-bosch-strasse; denzlingen, 79211 ; GM 79211
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5225020
• MDR Text Key: 31271638
• Report Number: 2916714-2015-01041
• Device Sequence Number: 1
• Product Code: GWG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PE184A
• Device Catalogue Number: PE184A
• Distributor Facility Aware Date: 10/16/2015
• Date Manufacturer Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Other