MAUDE Adverse Event Report: AESCULAP AG SHAFT COMPL.D:5MM L:310MM; APPLIERS LAPAROSCOPIC

Model Number PL522R

Device Problem Unintended Ejection (1234)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap ag that a shaft compl.D:5mm l:310mm (part # pl522r) was used during a procedure performed on an unknown date.According to the complainant, the clips were not pushed out from the applicator as normally.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).Involved components: pl510r: handle f/pl506r & pl508r: lot unknown.

Event Description

Involved components: pl510r - handle f/pl506r & pl508r - lot unknown.

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.Investigation results: visual investigation: the products arrived in a clean status with no visible damage.The maintenance date not met.Investigation was carried out visually and microscopically.Here we found misaligned jaws and that the maintenance date not met.Additionally the product was sent to the production department for further investigation.Due to the circumstance that the investigation is supported by the subject expert, this is a preliminary report.It will be updated when we received a statement from the subject expert.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

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.Investigation results: visual investigation: the products arrived in a clean status with no visible damage.The maintenance date not met.The investigation was carried out visually and microscopically.Here we found misaligned jaws and that the maintenance date not met.Additionally the product was sent to the production department for further investigation.Based on the analysis report of subject expert: "the cause can no longer be clearly determined.The jaws may have been displaced by improper use or this may be explained by the very long period of use (date of manufacture 05/2016) in conjunction with the maintenance not performed in 12/2020." batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

Event Description

Involved components: pl510r - handle f/pl506r & pl508r - lot unknown.

• Brand Name: SHAFT COMPL.D:5MM L:310MM
• Type of Device: APPLIERS LAPAROSCOPIC
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12134821
• MDR Text Key: 263178949
• Report Number: 9610612-2021-00493
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 04038653208463
• UDI-Public: 4038653208463
• 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: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL522R
• Device Catalogue Number: PL522R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PL510R - LOT UNKNOWN; PL510R - LOT UNKNOWN; PL510R - LOT UNKNOWN