MAUDE Adverse Event Report: AESCULAP AG MARYLAND DISSECTOR 5MM 310MM; ENDOSCOPY

Model Number PO102R

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 09/20/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: usa.It was reported that the lap maryland broke during surgery.The jaw snapped off when being used.Pieces had to be removed, which caused a 15 minute delay in surgery to make sure no more broken pieces remained in the patient.No harm to the patient was reported.

Manufacturer Narrative

The components have been examined visually and microscopically with a keyence vhx-5000 digital microscope and a (b)(6).We made a visual inspection of the instrument.First we investigated the outer tube.Here we found a broken ending and a broken off tip with a crack.Next we made a visual inspection of the metal inner tube.Here we found a deformed tip.Furthermore we investigated the shaft.Here we found a damaged shaft with a broken off jaw part.We made a visual inspection of the fracture surface of the broken adapter.Here we found discoloration.Additionally we investigated the broken off jaw part.Here we found visible damage.The root cause of the problem is most probably usage related.According to the quality standard, a production error and a material defect can be excluded.No pores or inclusions could be found on the point of rupture.We assume a mechanical overload situation as the causal factor and these will result with the breakages and damage.We assume that the discoloration are unknown residues.No capa is necessary.

• Brand Name: MARYLAND DISSECTOR 5MM 310MM
• Type of Device: ENDOSCOPY
• 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: 6139964
• MDR Text Key: 61538750
• Report Number: 2916714-2016-01009
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010752
• 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: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PO102R
• Device Catalogue Number: PO102R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/21/2016
• Date Manufacturer Received: 11/01/2016
• 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; Required Intervention