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

Model Number OP913

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was an issue with light cable diam.4.8 length.According to the customer description: "the failure was caused by increase of temperature and burning of impurities on fiber optic cable op 913 due to reduced light transmittance.During operation the cable was in light source op930, (the machine after functional test without fault).The patient or staff harm is unknown.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event/malfunction is filed under (b)(4).

Manufacturer Narrative

Involved component: axel xenon light source 180w (op930 51708259).General information: we received a complaint about a malfunction of a light cable.The cable op913 has been sent to schölly for investigation decontaminated.Light source op930 was not provided.Consequences for the patient: according to the available information, there were no negative consequences for the patient.Failure description: the cable has been sent to schölly for investigation directly.Investigation: according to the investigation report (attached to pc notification (b)(4)) residues can be found on the ends of the cable most likely caused by repeated insufficient cleaning of the cable.Due to this residues, a heat accumulation at the connection end of the cable occurred.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specifications valid at the time of production.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: based on the investigation of schölly, the increase of temperature was caused due to residues at the end of the cable.According to the ifu, do not use aldehydes or alcohols for pre-cleaning to avoid residues/proteins becoming fixated.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: 9758688
• MDR Text Key: 184446072
• Report Number: 9610612-2020-00043
• Device Sequence Number: 1
• Product Code: FSS
• Combination Product (y/n): N
• PMA/PMN Number: K984124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• 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: 02/14/2020
• Date Manufacturer Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1