MAUDE Adverse Event Report: AESCULAP AG TROCAR SLEEVE 5/110MM THREADED WITH TAP

Model Number EK016R

Device Problems Structural Problem (2506); Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: date of event is unknown.The reported complaint referenced multiple aesculap trocars; however, not all referenced products were returned for investigation.Two trocars of the same lot (ek017r / lot 52415436) and one karl storz manufactured shaft were returned for investigation.The returned trocars were in good condition with no deviations noted by visual inspection.There were several scratches noted on the insulation of the karl storz shaft.In addition to the returned instruments, pictures were provided to assist in the investigation.The provided insulation pipe does not correspond to the provided pictures.The damage seen in the photo (a chip in the insulation) was not located on the provided insulation pipe; however, scratches were recognized.Indications of wear and tear were found on the inside and the outside of the distal ends of both returned trocars.The device quality and manufacturing history records have been reviewed for all available lot numbers.The device history records were found to be according to specification valid at the time of production.One similar incident from the same end user has been filed with products from the reported batch.Based on the investigation of the returned devices as well as review of all available information indicates, the reported failure is related to insufficient use of the device.The distal ends of the provided trocars were worn, but still according to specification.The damage on the shaft of the returned device, as well as the damage noted in the photos provided, can only occur when high lateral forces are applied on the shaft during movement of the trocar.A worn or damaged distal end of the trocar can enhance this effect.The reported failure mode is being reviewed and revised, as appropriate, by r&d.At the time of this report, no corrective/preventive action has been identified.

Event Description

Country of complaint: (b)(6).It was reported that a 5 mm instrument (karl storz manufactured shaft) sheared during use with an aesculap manufactured trocar.According to information available at the time of this report, there was negative consequence to the patient.Seven different item numbers of trocars were reported.It is not clear which of these items was in use when the insulation sheared; therefore, one medwatch report is being submitted for each reported item number.All products and medwatch reports related to this report are: ek011r / 9610612-2018-00354; ek016r / 9610612-2018-00355; ek017r / 9610612-2018-00356; ek018r / 9610612-2018-00357; ek024r / 9610612-2018-00358; ek028r / 9610612-2018-00359; ek036r / 9610612-2018-00360.Karl storz shaft (item number unknown) / included as concomitant product in each of the above medwatch reports.

• Brand Name: TROCAR SLEEVE 5/110MM THREADED WITH TAP
• Type of Device: TROCAR
• 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
• MDR Report Key: 7795324
• MDR Text Key: 117580057
• Report Number: 9610612-2018-00355
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EK016R
• Device Catalogue Number: EK016R
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/25/2018
• Date Manufacturer Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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