MAUDE Adverse Event Report: AESCULAP AG LIGHTCABLE DIAM.4.8 LENGTH:2,5M; LAPAROSCOPIC SURGERY

Model Number OP913

Device Problem Temperature Problem (3022)

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

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the light cable.According to the complaint description the connection part between bt800r and op913 got so hot that the surgical cloth got burnt.Later on as these products were checked, the tempurature has risen to 50 degrees with 50% of light intensity for 3 hour-running.Additional information has been requested but not yet received as of this report.The customer suspected a loose connection.The adverse event/malfunction is filed under (b)(4).Associated medwatch-reports: 9610612-2020-00090 ((b)(4) bt800r).

Event Description

Additional complaint case was created with the following cc number 400471806.9610612-2020-00168 (400471806 op940).Associated medwatch-reports: 9610612-2020-00090 (400467186 bt800r).

Manufacturer Narrative

General information we received a complaint about one nx058z as vega ps tibial plateau cemented t4+ from the (b)(6) hospital, (b)(6) usa.Up to now neither the affected device nor the package is available for investigation.Consequences for the patient surgery delay longer than 15 minutes.Investigation is not possible; no product at hand.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and found to be according to our 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 it is not possible to determine a definitive root cause for the failure.It could be possible that the mentioned failure is package related (related due to several delivery processes).Rationale on the basis of the current information and without a product for investigation, a clear conclusion can not be drawn.The device history records have been checked and no abnormalities could be observed.From our experience (on the basis of similar cases described) it could be possible that the mentioned powder substance on the surface of the implant resulting from contact between the implant and the pe packaging component of the primary packaging.On the basis of the manufacturing date (2014) most probably the complained device is part from a loan service.Therefore it could be possible that a high level of workload due to several delivery processes lead to a complete damage of the packaging oxygen reached to the product and lead to the mentioned discoloration.Corrective action for the mentioned problem a capa was created.Please note the associated recall, in progress.

Manufacturer Narrative

Associated medwatch-reports: 9610612-2020-00090 (400467186 bt800r); 9610612-2020-00091 (400467187 op913); 9610612-2020-00168 (400471806 op940).General information: we received a complaint about a malfunction of a retractor handle in combination with a light cable.The bt800r is available for investigation at aag, the op913 has been forwarded the "schölly" for investigation.Op940 was not sent in for investigation.Consequences for the patient: according to the available information, there were no negative consequences for the patient.Investigation: vigilance investigator carried out the pictorial documentation visually bt800r: no deviation could be found at the provided bt800r handle, especially at the connection point.Op913: according to the 8d-report of schölly (attached to pc notification (b)(4), no deviation, especially burnt fibres, can be found at the provided light cable.Furthermore a functional test was carried out successfully.Combination bt800r & op913: functional test bt800r in combination with op913 and a light source op950 was carried out by ats.A temperature of 48,5°c was measured at the connection point.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and found to be according to our specifications 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 an insufficient usage.Rationale: according to the ifu of the light source op940, there is a risk of burns from excessively high operating temperatures.The optical cable socket and optical cable connections get hot.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action and preventive action), a capa is not necessary.

• Brand Name: LIGHTCABLE DIAM.4.8 LENGTH:2,5M
• Type of Device: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9912368
• MDR Text Key: 186212080
• Report Number: 9610612-2020-00091
• Device Sequence Number: 1
• Product Code: FSS
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2020

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: OP913
• Device Catalogue Number: OP913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 04/30/2020; 06/04/2020
• Supplement Dates FDA Received: 05/27/2020; 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1