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: 2916714-2015-01041.

Manufacturer Narrative

Investigation: the investigation was carried our at aesculap fleximed.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and found to be according to specification valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to a sterrad nx processing of the device.No capa is necessary.

• 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 AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5225024
• MDR Text Key: 31245366
• Report Number: 2916714-2015-01042
• 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,Followup
• Report Date: 03/19/2018

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
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/16/2015
• Date Manufacturer Received: 10/16/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other