MAUDE Adverse Event Report: AESCULAP AG CAIMAN DISP.INSTR.ARTICULAT.D5/360MM; LAPAROSCOPIC SURGERY

Model Number PL741SU

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2020

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 caiman disp.It was reported that the plastic of the blister pack was "glued" to the cable, according to the operating management.Therefore, it became unsterile on removal and had to be discarded.There was no patient harm.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: the device was provided in the original box and pulled off sealing.At first we made a visual inspection of the cord and the inner side of the blister.Here we detected no abnormalities.In the next step we took the instrument out of the blister and wiped several times with a cotton ball along the cavity of the cord.We did not notice any lint sticking, neither in the blister nor on the cord.The manufacturing documents have been checked and found to be according to specification valid during the time of production.There are no further complaints with this lot at hand.The root cause for the described problem cannot be determined, the problem itself could not be confirmed.

Manufacturer Narrative

Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file - no malfunction or serious injury.

• Brand Name: CAIMAN DISP.INSTR.ARTICULAT.D5/360MM
• Type of Device: LAPAROSCOPIC SURGERY
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10385287
• MDR Text Key: 203523467
• Report Number: 9610612-2020-00359
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151696
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2022
• Device Model Number: PL741SU
• Device Catalogue Number: PL741SU
• Device Lot Number: 52596221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1