MAUDE Adverse Event Report: AESCULAP AG ENDOSCOPY; REUSABLE TROCAR SYSTEMS

Model Number EK083P

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that during a laparoscopic procedure the valve detached and fell into the patient's cavity.The surgeon detected the part of the device and retrieved it from the patient's body.

Manufacturer Narrative

Investigation: the components have been examined visually and microscopically with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.We made a visual inspection of both devices.First we investigated the reusable valve unit.Here we found cracks and eruption on the momentive lsr 2640 and we found cracks and fine cuts on the wacker elastosil lr-3003/80 of the blinding-cap ek087250.Additionally we found a deformed momentive lsr 2640 on the blinding-cap ek087251.Furthermore we investigated the reusable valve unit.Here we found cracks on the momentive lsr 2640 and we found cracks, damaged surface and fine cuts on the wacker elastosil lr-3003/80 of the blinding-cap ek087250.Additionally we found a deformed momentive lsr 2640 on the blinding-cap ek087251.Conclusion and root cause: the root cause of the problem is most probably usage related.Rational: the fracture surface exhibits signs of fine cuts.We assume that the cracks and eruption were caused by during insertion of the instrument.Additionally there is the possibility that the devices were over-reprocessed and the sensitivity increased.There are no signs of aging like discoloration or brittleness.No capa is necessary.

• Brand Name: ENDOSCOPY
• Type of Device: REUSABLE TROCAR SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• 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: 6546078
• MDR Text Key: 74514987
• Report Number: 9610612-2017-00218
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2017

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 Model Number: EK083P
• Device Catalogue Number: EK083P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/17/2017
• Initial Date Manufacturer Received: 03/15/2017
• Initial Date FDA Received: 05/04/2017
• Supplement Dates Manufacturer Received: 03/15/2017
• Supplement Dates FDA Received: 10/18/2017
• 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
• Patient Outcome(s): Other